PROJECT REPORT

ON
QUALITY CONTROLLED ROLE OF BIOCHEMIST
IN PHARMACEUTICAL CHEMISTRY

Dissertation submitted to the Bahra University in partial

fulfilment of the requirements for degree of
MASTER IN SCIENCES
BIOCHEMISTRY
By
RUCHIKA

(Reg. No.BU2017PGBIO017)

SCHOOL OF PHARMACEUTICALS SCIENCES

BAHRA UNIVRESITY, WAKNAGHAT, SHIMLA HILLS, H.P.
June-2019
CERTIFICATE
 ACKNOWLEDGEMENT

I would like to express my gratitude to IBN Herbal (P) Ltd. Baddi for giving me the opportunity
to undertake my Industrial Training program in the company which gave me an insight into the
working of the oragnization as a whole.

I am very grateful to Mr. Anil Kumar, HR manager, IBN Herbal (P) Ltd. for giving me an
opportunity to undertake my Industrial Training program at IBN Herbal.

I owe my sincere thanks and heartfelt gratitude to Mr. Anil Kumar, HR manager who has been
instrumental in the successful completion of this project. I am thankful for his guidance and
constant supervision for providing necessary information regarding the successful completion
of the project. I would like to express my gratitude towards employees of IBN Herbal (P) Ltd. for
their kind co-operation and encouragement. Their contribution gave me valuable insights into
this project and immense knowledge of the area.

I emphatically express my thanks to Gurvinder. S. Bahra (Chancellor, Bahra university), Dr.

S.K.Bansal (Vice Chancellor) ,Dr. A. Banerjee. (Dean, School of Pharmaceutical science.) and
to our program manager Dr. Aprajita Bhardwaj for permitting me to do my research work at
IBN Herbals at Baddi.

Under the leadership and guidance of “Mr. Sumit Singla (Proprietor)” we have been able to
achieve the goal of our firm in a well-defined manner. His constant levels of focus and promise
helps us to attain a huge client base.

My deep sense of thanks to Mr. Vitin Dhaka and Paramjeet Kaur for their support in
laboratory.

My deepest gratitude goes to my parents and family for their love and moral support throughout
my life and being a constant source of inspiration to build up my education career.

I request indulgence from many friendly & helpful people whom I could not name here, due to
paucity of space. Needless to say, all omissions and errors are mine.
 ABSTRACT:

A simple, economical, specific, accurate, precise and validated Reverse phase high performance
liquid chromatography (RP-HPLC) method has been developed for simultaneous estimation of
Phenylepherine hydrochloride (PPEH) and Cetirizine hydrochloride (CETH) in combine dosage
form. The chromatographic separation was achieved on Princeton SPHER C18 column (250 mm
x 4.6 mm id, 5 μ particle size) at ambient temperature using mobile phase buffer (0.1 M
Ammonium dihydrogen phosphate pH 5.2 ± 0.05): Acetonitrile (50:50% v/v) at flow rate 1.0
ml/min. Quantification was achieved with UV detector at 225 nm. Retention time of
Phenylepherine hydrochloride and Cetirizine hydrochloride were found to be 2.19 ± 0.05 minute
and 4.16 ± 0.05 minute respectively. Linearity was studied in the concentration range 5-30 μg/ml
and 10-60 μg/ml for Cetirizine hydrochloride and Phenylepherine hydrochloride respectively
with a correlation coefficient of 0.9998 and 0.9998 respectively. The proposed method was
validated according to ICH guidelines with respect to linearity, accuracy, precision, robustness,
LOD, and LOQ. The developed method with good separation, successfully applied for
determination of PPEH and CETH in its pharmaceutical dosage form
 CONTENT

Chapter TITLE PAGE NO.

1 INTRODUCTION

2 REVIEW OF
LITRARTURE

3 MATERIAL AND
METHODS

4 CALCULATIONS AND
RESULTS

5 CONCLUTION

6 REFRENCES
 CHAPTER - 1
INTRODUCTION

Quality control is a process that is carried out to ensure a desired level of quality in a product or
service. It might include whatever actions a business deems necessary to provide for the control
and verification of certain characteristics of a product or service. Most often, it involves
thoroughly examining and testing the quality of products or the results of services. ISO 8402-
1986 standard defines that quality is the totality of features and characteristics of a product or
service that bears its ability to satisfy stated or implicated needs 1 . Pharmaceutically, we can say
quality is checking and directing the degree and grade of experience of process and products 2 .
This process is carried out to validate the product quality, to produce medication of superior
efficacy, safety, and to provide assurance to physician, pharmacists and patients as well that
given product performs satisfactorily and uniformly. When a number of different formulations
are available for the same drug, it becomes essential to ensure the equivalency (relationship
followed by bioavailability, therapeutic response, or a set of established standards of one drug
product to another 3 ) of the products pharmaceutically. Cetirizine is a long acting antihistamine
and unlike conventional or first generation antihistamines it causes less sedation and
psychomotor impairment and as well causes no behavioral changes. It is a major metabolite of
hydroxyzine, and a racemic selective H1 receptor antagonist used in the treatment of allergies,
hay fever, angioedema, and urticaria. The basic goal of our study was to ensure that the products
(cetirizine tablets) that are saturated in Bangladeshi drug market meet specific requirements and
characteristics,

Established in the year 1971, in Solan, (Himachal Pradesh, India), we “IBN Herbals” are a

Sole Proprietor firm, actively engaged in manufacturing and supplying an extensive range
of Antibiotics Tablets, Pharmaceutical Capsules, Nutraceutical products, Beta Lactam
Antibiotic Products, Antiallergic Drugs, Cephalosporin Category Products and General
Products. The herbal medicines provided by us are processed by utilizing supreme quality
natural ingredients and sophisticated machines under the meticulous surveillance of our
dexterous professionals in accordance with set medical standards. These herbal medicines are
highly admired among our prestigious clients owing to their salient features such as long shelf
life, accurate composition, non-allergic, free from impurities, highly effective, precisely
processed, etc. Additionally, we provide these herbal medicines in variegated packaging options
as per the requirements of our valuable clients with no hassle. Clients can easily purchase these
herbal medicines from us at rock bottom prices with no hassle.
To process the best quality herbal medicines, we possess innovative and advanced infrastructural
facility. We have further integrated our infrastructure facility into numerous departments such as
processing department, quality control department, logistic department, administration
department, research & development department, transportation department and warehousing &
packaging department. These departments are well-resourced with ultra-modern techniques,
machines and tools that are lubricated and serviced at regular interval in order to enhance the
production capacity. All these departments are supervised by our team of hardworking and adroit
professionals in order to accomplish the voluminous requirements and necessities of our
prestigious customers. With the relentless efforts and dedication of our team members, we have
been able to achieve a renowned and dynamic position among our customers. 

Under the leadership and guidance of “Mr. Sumit Singla (Proprietor)” we have been able to
achieve the goal of our firm in a well-defined manner. His constant levels of focus and promise
helps us to attain a huge client base.
 Phenylepherine hydrochloride (PPEH) chemically described as (R)-1-(3-hydroxyphenyl)-2-
methylamino ethanol hydrochloride is a sympathomimetic (alpha-adrenergic) agent 1 who
stimulates alpha-adrenergic receptors, producing pronounced vasoconstriction 2. It is also a
frequent constituent of orally administered nasal decongestant preparations 3. It is officially in
IP 1, BP 4 and USP5.
Cetirizine hydrochloride (CETH) chemically described as [2-[4-[(4-chlorophenyl) phenyl
methyl]-1piperazinyl]ethoxy] acetic acid, dihydrochloride is an antihistaminic 1, histamine H1
receptor antagonist 4 and an anti-allergic agents  used in the treatment of seasonal rhinitis, hay
fever, running nose, control sneezing of allergic origin 3.
The levorotatory enantiomer of Cetirizine, known as Levocetirizine is more active form 7.
Cetirizine hydrochloride is official in IP 1, BP 4 and USP 5. Literature survey reveals that several
analytical methods have been reported for the determination of PPEH and CETH as individual
and combined dosage form with each other and with other combination of other drugs such as
 RP-HPLC, Spectrophotometric, HPTLC, Fluorimetry and ion-pair Chromatographic method 8-20.
Our objectives in the present investigation are to develop and validate new RP-HPLC method for
simultaneous determination of PPEH and CETH. The proposed RP-HPLC method utilise
economical solvent system having advantages like better retention time, very sharp sssand
symmetric peak shapes. The proposed method was validated according to ICH guidelines 6.

Chemical structures of PPEH and CETH: 

1. FIG. 1: CHEMICAL STRUCTURE OF

CETH 

FIG. 2:  CHEMICAL STRUCTURE OF PPEHMATERIALS AND METHOD:

Instrument and apparatus: A HPLC Instrument (LC-2010 CHT, Shimadzu, Japan)
equipped with UV detector, auto injector and LC-Solution Software was used. The
chromatographic analysis was performed on Princeton SPHER C18 Column (250mm x
4.6mm id, 5 μ particle size). Analytical balance (Mettler Toledo), digital pH meter (Eutech
instruments pH tutor) was used during analysis.
 Reagents and Materials:
Working standards of PPEH (potency = 99.45%) and CETH (potency = 99.12%) were obtained
as a gift samples from Cipla Ltd. Mumbai. HPLC grade Acetonitrile, AR grades
Orthophosphoric acid and Ammonium dihydrogen phosphate were procured from Merck Ltd.
Mumbai India. Water was purified with Milli-Q Millipore system. All the solvents and solutions
were filtered through a 0.45µ membrane filter paper. The commercial fixed dose combination
product Alerid-D tablet (Marketed by Cipla Ltd. Mumbai) containing 10 mg PPEH and 5 mg
CETH was procured from the local market.
 CHAPTER 2
LITERATURE REVIEW

Guided by pharmacology and clinical sciences, and driven by chemistry, pharmaceutical

research in the past has played a crucial role in the progress of development of pharmaceuticals.
The contribution of chemistry, pharmacology, microbiology and biochemistry has set a standard
in the drug discovery where new drugs are no longer generated only by the imagination of
chemists but these new drugs are the outcome of exchange of ideas between biologists and
chemists. The process of drug development starts with the innovation of a drug molecule that has
showed therapeutic value to battle, control, check or cure diseases.
The synthesis and characterization of such molecules which are also called active pharmaceutical
ingredients (APIs) and their analysis to create preliminary safety and therapeutic efficacy data
are prerequisites to identification of drug candidates for further detailed investigations
(Valagaleti et al., 2003). The investigations on the pre drug discovery are based on knowing the
basic cause of the disease to be treated, the information on how the genes are altered that cause
the disease, the interaction of proteins and the affected cells and changes brought by these
affected cells and how they affect these cells. Based on these facts a compound is developed
which interacts with the affected cells and finally could become the drug molecule or active
pharmaceutical ingredient (A.P.I) Drug discovery and Development, understanding the R&D
process.
The “compound” which is set to become the drug molecule undergoes safety tests and a series of
experiments to prove that it is absorbed in the blood stream, distributed to proper site of action in
the body, metabolized sufficiently and demonstrates its non-toxicity thus, can be considered safe
and successful. Once the compound is finalized the preclinical research i.e. in vitro studies
followed by the animal testing to check kinetics, toxicity and carcinogenicity tests are performed.
After passing the pre-clinical tests the regulatory authorities grant permission for the clinical
trials. The clinical trials check whether the drug is working in the proposed mechanism or not, its
optimum dose and schedule while the last two stages generate statistically important data about
efficacy, safety and overall benefit–risk association of the drug. In this phase the potential
interaction of the drug with other medicines is determined and monitors drug’s long term
effectiveness. After a successful completion of the clinical trials, the drugs are launched in the
market for patients. 
CHAPTER-3
MATERIAL AND METHODS

Chromatographic Condition:

HPLC system LC-2010 CHT , Shimadzu

Software LC Solution

Detector UV  Detector

Wavelength 225 nm

Pump Isocratic Pump

Princeton SPHER, C18(250 mm x 4.6 mm id, 5μ

Stationary phase
particle size)

0.1 M Ammonium dihydrogen phosphate buffer (pH

Mobile phase
5.2 ± 0.05) : ACN (50:50 v/v)

Flow rate 1.0 ml/min

Injection volume 20 μl

Preparation of stock and standard solutions:

A Stock solution of PPEH (1 mg/mL) was prepared by dissolving 100 mg PPEH in 100 ml
volumetric flask and volume make up by mobile phase.  CETH (0.5mg/ml) was prepared by
dissolving 50 mg CETH in 100 ml volumetric flask and volume make by mobile phase.
Appropriate volumes of the stock solution were transferred to appropriate volumetric flask and
solution was diluted with mobile phase to furnish final concentration of PPEH and CETH in the
range 10-60μg/ml and 5-30μg/ml respectively.

Preparation of Tablet dosage form:

20 tablets (Alerid-D Tablet) each contained 10 mg PPEH and 5mg CETH were accurately
weighed.  Their average weight determines and finally powdered.  Quantity of the powder
containing weight equivalent to 100 mg PPEH and 50 mg CETH were transferred to 100 ml
volumetric flask and 50 ml mobile phase was added followed by ultra sonication for 10 minute
and make up the volume up to 100 ml with mobile phase. The resulting solution stirred for 1
hour.  After that centrifuged at 2000 RPM for 5minute further dilution was performed with
mobile phase to reach the calibration range for each compound.
Method Validation:
The proposed method was validating according to ICH (Q2) B Guidelines for validation of
analytical procedures.  As per the ICH guidelines the method validation parameters checked
were linearity, accuracy, precision, assay, robustness, LOD, LOQ.
Linearity (Calibration Curve):
For constructing calibration curve, series of six dilutions in the concentration range 10-60 (10,
20, 30, 40, 50, and 60) μg/ml for PPEH and 5-30 (5, 10, 15, 20, 25, and 30) μg/ml for CETH was
taken. Calibration curve were constructed by plotting peak area vs. concentration of PPEH and
CETH and regression equation calculated from calibration curve. Linearity curves have shown
in Fig. 5 and 6 respectively.

Accuracy (% Recovery):
The accuracy of the method was determined by calculating recovery of PPEH and CETH by the
standard addition method.  Known amounts of standards solutions of PPEH and CETH added at
80,100 and 120% level to prequantified sample solution of PPEH and CETH. Three samples
were prepared for each recovery level solutions were then analysed and the percentage recovery
were calculated by using formula.
Precision:
The precision of analytical procedure express degree of the agreement among individual test
when the procedure is applied repeatedly to multiple sampling of homogenous samples.
Precision are considered at two levels: Repeatability and Reproducibility.
Method Precision (Repeatability):
The precision of the instrument was checked by repeatedly injecting (n =6) standard solutions of
the PPEH and CETH. Under the same Chromatographic condition and measurements of % RSD
of peak area, retention time, and tailing factor should not be more than 2%.
Intermediate Precision (Reproducibility):
The intraday and interday precision of the proposed method was determine by analysing the
corresponding responses 3 times of the same day and on three different days over a period of 1
week for three different concentration of standard solutions of PPEH (10, 20 and 30 µg/ml) and
CETH (5, 10 and 15 µg/ml) the results were reported in the terms of % RSD.
Robustness:
The robustness of the method was established by introducing small changes in various
parameters like, pH of mobile phase, flow rate, wavelength, column temperature and mobile
phase composition. The method was evaluated by calculating % RSD.
Limit of Detection & Limit of Quantification:
Limit of detection (LOD) was lowest concentration of analyte in the sample that could be
detected under the stated experimental condition and Limit of quantification (LOQ) the lowest
concentration of the active ingredients in a sample that could be determined with accepted
precision and accuracy. According to ICH recommendation, the approach based on the standard
deviation (SD) of the response and slope (M) was used for determining the detection and
quantification limits. LOD can be calculated according to formula LOD = 3.3 (SD/M) and LOQ
= 10(SD/M). The signal to noise ratio was determined. The LOD was regarded as the amount for
which the signal to noise ratio was 3:1 & LOQ as the amount for which the signal to noise ratio
was 10:1.
 CHAPTER -4
RESULTS AND DISCUSSION:
To optimize the HPLC parameters, several mobile phase composition were tried.

FIG. 3: CHROMATOGRAM OF PPEH AND CETH IN STANDARD SOLUTION.

A good peak symmetry, a satisfactory resolution for PPEH and CETH was obtained with mobile
phase buffer (pH 5.2 ± 0.05): ACN (50:50 v/v) at a flow rate 1 ml/min to get better
reproducibility and repeatedly optimization of method was done by changing mobile phase
composition, pH of mobile phase, column packing, flow rate, temperature, detection wavelength
and the effect on retention and peak shape were monitored for PPEH and CETH. Typical
chromatogram of PPEH and CETH.
FIG.4: CHROMATOGRAM OF PPEH AND CETH IN SAMPLE SOLUTION.
1] System suitability test parameters for PPEH and CETH for the developed method are reported
in Table 1.
TABLE 1: SYSTEM SUITABILITY TEST PARAMETERS FOR PPEH & CETH

CETH ± RSD
Parameters PPEH ± RSD (n=6)
(n=6)

Retention Time (min) 2.19 ± 0.187 4.16 ± 0.104

Tailing Factor 1.42 ± 0.365 1.38 ± 0.373

Theoretical plates 2919 ± 0.316 5004 ± 0.367

Resolution 9.094 ± 0.652

RSD: - Relative standard deviation

2] The method showed good linear response in the concentration range 10-60 μg/ml for PPEH
(r2 = 0.9998) and 5-30 μg/ml for CETH (r2 = 0.9998)
 FIG.5: LINEARITY CURVE OF PPEH

2. FIG. 6: LINEARITY CURVE OF CETHTABLE 2: REGRESSION ANALYSIS OF THE

CALIBRATION CURVES FOR PPEH & CETH (N=6).

Parameters PPEH CETH

Linear range (µg/ml) 10-60 5-30

Slope 21607 31822

Intercept 15079 524.07

Correlation Coefficient (r2) 0.9998 0.9998

3. 3] The method was found to be precise and RSD was found to be less than 2% are given
in                  Table 3.

4. TABLE 3: PRECISION OF RP-HPLC METHOD

Intraday amount found (%) Interday amount

Drugs Level (n=3) found (%)
±RSD ±RSD

100.68±0.682
1 101.63±0.541

  99.25±0.861
2 100.02±1.201
PPEH

98.75±1.652
3 98.92±0.925

99.56±1.203
1 98.65±0.621

  100.62±1.652
2 98.95±0.792
CETH

98.65±0.256
3 99.45±0.994

5. 4] The results of recovery of PPEH and CETH with the RSD less than 2% are given in Table 4.
6. TABLE 4: RECOVERY STUDIES OF PPEH AND CETH

Drugs Level (n=3) % Recovery ± % RSD Mean recovery

80 % 100.96±1.18
   
100 % 100.95±1.88
PPEH 100.47%
120 % 99.50±0.95

80 % 98.43±0.80
   
100 % 98.88±1.13
CETH 99.34%
120 % 100.72±0.18

7. 5] Assay of PPEH and CETH shown in Table 5.

8. TABLE 5:  RESULTS OF TABLET ASSAY OF PPEH AND CETH

Amount of drug %
Drugs Label claim (mg/tab) estimated Amount
(mg/tab) found

PPEH 10.0 10.095 100.95

CETH 5.0 4.944 98.88

9. 6] LOD and LOQ value of PPEH and CETH was determined by residual standard deviation
method. The results are given in Table 6.
10. TABLE 6: LOD AND LOQ OF PPEH AND CETH

LOQ
Drugs LOD (µg/ml)
(µg/ml)

PPEH 0.176 0.533

0.248 0.750

11. 7] Robustness was evaluated by varying different parameters. The results of these variations are
given in Table 7.

12. Ssssss

PPEH CETH

Parameters Variatiossssn
Retention Retention
Assay (%)
time(min) time(min)

0.9 2.44 99.52 4.63

Flow rate(ml/min) 1.0 2.19 100.21 4.16

1.1 1.99 98.56 3.78

pH 5.0 2.19 99.56 4.16

 5.2 2.19 99.23 4.16

5.4 2.19 99.98 4.16

24 2.19 100.95 4.16

Column temperature (0C) 25 2.19 99.56 4.16

26 2.19 101.65 4.16

224 2.19 101.85 4.16

Wavelength(nm) 225 2.19 100.90 4.16

226 2.19 99.37 4.16

(60:40) 2.34 101.88 6.34

Mobile Phase
(50:50) 2.19 99.51 4.16
Composition
(40:60) 1.55 98.66 3.88

Why it’s used

If you have year-round symptoms, or seasonal allergies like hay fever, your doctor may
recommend cetirizine. Cetirizine may help relieve these allergy symptoms, but it doesn’t prevent
them.

When you come in contact with allergens, your body produces a chemical called histamine.
Histamine causes most of the symptoms related to allergic reactions. Cetirizine is an
antihistamine. It blocks the effects of histamine.
Cetirizine helps relieve mild to moderate allergy symptoms, such as:

● sneezing

● runny nose

● itchy or watery eyes

● itchy throat or nose

These reactions can happen after you touch or inhale allergens such as plant pollen, mold, or pet
dander. Allergies usually affect your nose, sinuses, throat, and other areas of your upper
respiratory system.

Cetirizine also helps relieve hives. They are itchy, raised rashes on the skin. Hives often occur
with food or medication allergies.

How to take it

Adults and children 2 years and older can take the syrup, which is fruit flavored. Adults and
children 6 years and older and take the capsules and tablets.

The usual dosage for adults younger than 65 and children who are 6 years and older is one 10-
milligram (mg) dose per day. You shouldn’t take more than 10 mg in 24 hours. Your doctor may
recommend a 5-mg dose once or twice per day if your allergies are mild.

Talk to your doctor about dosage for people who:

● are 2 to 6 years old

● are older than 65 years

● have liver or kidney disease

Cetirizine side effects

Cetirizine is a newer, second-generation antihistamine. Unlike first-generation antihistamines,
cetirizine is less likely to cause side effects such as dangerous drowsiness, dry mouth, blurred
vision, and overheating.

That said, Cetirizine can cause adverse effects, such as:

● drowsiness

● excessive tiredness

● dry mouth

● stomach pain

● diarrhea

● vomiting

Tell your doctor about any unexpected side effects that you have while taking cetirizine. Also,
discuss any ongoing or bothersome side effects. These effects are usually not emergencies.

Precautions and warnings

Be careful using machinery

Even though cetirizine doesn’t usually cause drowsiness, some people respond differently when
taking it, especially in the first few doses. Be cautious, and don’t drive your car or use machinery
until you know for sure how your body will respond to cetirizine.

Check the ingredients

Don’t use cetirizine if you have ever had an allergic reaction to it or to any of the ingredients in
it. Also, steer clear of cetirizine if you are allergic to any antihistamine that contains
hydroxyzine.
Don’t use during pregnancy and breastfeeding

Talk to your doctor before you take cetirizine if you are pregnant or planning to become
pregnant. Taking cetirizine is generally not recommended during pregnancy. It’s also not
recommended if you breastfeed your child. This is because the drug passes into breast milk.

Talk to your doctor

If you have liver or kidney disease, ask your doctor about taking cetirizine. If your doctor feels it
is safe for you to take, they may recommend taking less than the typical dosage.

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Interactions with cetirizine

Cetirizine does interact with other substances. For example, avoid consuming alcoholic drinks
while you take cetirizine. Doing so may be dangerous. Mixing cetirizine with alcohol can cause
drowsiness or make you less alert.

If you take any type of tranquilizer, sedative, or sleep aid, make sure to ask your doctor before
you use cetirizine. Mixing cetirizine with drugs that depress your central nervous system can
amplify sedation. It can further impair your mental and nervous system functions.

There is a possibility of a drug interaction between cetirizine and theophylline. Theophylline

(Theo-24, Theolair) is a drug that some people with asthma and other lung problems take.
However, the interaction is most likely dose-related. It has only been reported with daily
theophylline doses of 400 mg or more. In these cases, it took longer for cetirizine to leave the
body. Talk to your doctor if you take theophylline and are considering cetirizine.
Cetirizine-D

Cetirizine-D and brand-name versions, such as Zyrtec-D, are combination drugs. The “D” stands
for decongestant. These drugs contain both cetirizine and the decongestant pseudoephedrine.

Your doctor may tell you that cetirizine-D is not for you if you have any of these conditions:

● heart disease

● thyroid disease

● diabetes

● glaucoma

● high blood pressure

● enlarged prostate with urinary retention

Talk to your doctor

Cetirizine is an over-the-counter drug that can relieve mild to moderate allergy symptoms. Like
any drug, especially over-the-counter medication, you should understand all of the
considerations before you start taking it.

Talk to your doctor about any questions you have about your symptoms and any other conditions
you may have. Your doctor may recommend a different antihistamine or a combination drug of
cetirizine and another product. It may require a prescription.

Here are a few questions you might ask your doctor about cetirizine:

● Is cetirizine a good choice for me? What are my options and alternatives?

● How often should I take cetirizine, and how much should I take?

● What effects will I notice after I take cetirizine?

 ● Can I take cetirizine with my other medications and health conditions?

● Are there any other dangers or risks associated with this medication?

● What are the signs of an emergency, and what should I do in case of an emergency?

Cetirizine: uses, benefits and side effects

Quick facts
● Cetirizine is also known by the brand name Zirtek.

● 5.5 million items of cetirizine hydrochloride were prescribed by GP surgeries in England in 2017
(source: openprescribing.net).

Treating allergies with cetirizine

Cetirizine (set-IRI-zeen) is an anti-allergy medicine that belongs to a class of drugs
called second-generation antihistamines. It is used to treat hay fever, allergic conjunctivitis,
eczema, food allergies, insect bites and hives.
The generic version is commonly labelled as cetirizine hydrochloride, which is the full name of
the active ingredient.
The medicine is available both on prescription and over the counter. It comes either as tablets,
capsules and oral liquids.
Cetirizine should be stored in a dry place at 15C to 30C.
 Is cetirizine the same as Benadryl?
Yes and no. The Benadryl brand family (which you’ve probably seen in high-street pharmacies
and supermarkets) actually encompasses a number of different generic antihistamines. The
generic name for the original version of Benadryl is acrivastine. Benadryl One-a-Day is the
cetirizine version of the drug.
To confuse matters somewhat further, there are other over-the-counter brands that have a
cetirizine line, such as Piriteze (which is one of the largest antihistamines by volume sales). Ask
your pharmacist if you have any questions related to the different types of cetirizine available.
For a more in-depth understanding of the key differences between generic medicines and brand-
name medicines, our article explains all.
Is cetirizine a sleeping pill?
No. Cetirizine is a non-drowsy antihistamine, meaning it’s much less likely to make you feel
sleepy than other types of antihistamine (unless mixed with certain medications or substances).
How does it work?
Like other antihistamines, cetirizine works by blocking the natural chemical histamine, which
gets secreted during an allergic reaction in the body.
Histamine causes the symptoms that are associated with allergy. These include:
● itchy, red, watery eyes

● sneezing

● a runny, itchy nose

● itchy, sometimes visibly red skin.

As an antihistamine, cetirizine counteracts the effects of histamine and helps relieve you of these
symptoms of allergy.
Cetirizine dosage information
Adults take cetirizine once a day, although some children may be directed to take a smaller syrup
dose twice a day. The usual daily dosage of cetirizine for adults under the age of 65 is 10mg
(milligrams) a day.
For children, the typical dose is between 2.5mg and 5mg.
The dose you receive will depend on the severity of your allergic reaction. If you have any
questions about the dose you have been given, ask your prescribing GP or pharmacist.
How and when to take cetirizine
For adults, take cetirizine once a day. It’s up to you what time you take the medicine - just make
sure you stick to roughly the same time every day.
Cetirizine can be taken with or without food. If you are taking cetirizine tablets or capsules,
always take with a glass of water, juice or milk. Swallow them whole and do not chew.
If you are using oral liquid cetirizine, make sure you use the special measuring spoon that comes
with the medication. Do not use a kitchen spoon, as this can give you a low or excess dose. If
your medication did not come with the measuring spoon, ask your local pharmacist for a
replacement.
Never double dose to make up for a missed dose.
Cetirizine is usually very safe. If you take more than directed, you or your child may experience
common side effects. Contact your GP if you’ve taken too much.
What are the side effects of cetirizine?
 Common side effects of cetirizine occur in more than 1 in 100 people. Visit your GP if you
experience any of the following:
● headache

● dry mouth

● feeling sick

● dizziness

● diarrhoea

● cold-like symptoms

● sore throat

Sore throat is a common side effect of cetirizine.

If these side effects do not improve after a week, then your GP may lower the dose or take you
off the medication altogether.
Cetirizine interactions
According to the NHS, cetirizine can interact with the following medicines when taken together:
● midodrine, a medicine used to treat low blood pressure;
● ritonavir, a medicine used to treat HIV infection;
● any medicine that makes you drowsy, gives you a dry mouth, or makes it difficult for you to
urinate. Taking cetirizine might make these side effects worse.

A full list of interactions with cetirizine can be found on the NICE website. For further advice,
ask your GP or pharmacist.
Cetirizine contraindications
Cetirizine and alcohol together can make you feel drowsy, so it’s best to lay off the booze while
you take cetirizine.
There are some instances where cetirizine may not be suitable to take.
Before taking cetirizine, you should tell your GP if you:
● have a liver, heart or kidney disease

● have urinary retention problems

● have an allergy to peanuts or soya

● have an allergy to the food additives E218 and E216

● have epilepsy or another condition that puts you at risk of seizures

● are pregnant or breastfeeding a child

Cetirizine can also impair mental alertness, so do not drive or operate heavy machinery when
you are taking the medication. If you job requires you to do either of these, make it a priority to
speak to your GP about the situation.
Cetirizine and allergy tests
Cetirizine may interfere with the results of an allergy test, and should be stopped three days
before the taking of the test to get accurate results. If you have an allergy test planned, do not
come off cetirizine without your GP’s consent. Instead, consult your GP well in advance of the
test to ensure you’ll minimise the chances of withdrawal symptoms developing when you
discontinue the medication.
What’s the easiest way to get cetirizine?
If you’ve been authorised by your GP to take cetirizine on repeat prescription, the medicine is
available for sale over the counter in small pack sizes from pharmacies and many other retail
locations.

CHAPTER 5

CONCLUSION

 A validated RP-HPLC method has been developed for the determination of Phenylephrine
Hydrochloride and Cetirizine Hydrochloride in tablet dosage form. The proposed method is
simple, rapid, linear, accurate, precise and specific. Results from the validation experiments
showed that the method is reliable and accurate therefore it can be successfully applied for the
routine quality control analysis of Phenylepherine Hydrochloride and Cetirizine Hydrochloride
in tablet dosage form Cetirizine
Overview

Cetirizine is an allergy medication that you can buy over-the-counter at a pharmacy. That is, you
don’t need a prescription. The medication comes in capsules, tablets, and a syrup. You typically
take it just once per day, and it begins to work quickly. It’s inexpensive, too — usually less than
$1 per day for brand-name versions (Zyrtec, Aller-Tec, and Alleroff), and even less for generic
products.

Generally, cetirizine is a safe and effective drug, but you should be aware of certain warnings
and precautions when taking this drug. Learn how this drug works, what it’s used for, and how to
take it safely.

CHAPTER 6

REFERENCES

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