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(I) Introduction: Basic Pharmaceutical Analysis

This document provides an introduction to basic pharmaceutical analysis. It discusses key topics including the purpose of pharmaceutical analysis to identify, determine, measure, and understand compounds. Analysis can be used in research, industry, hospitals, and other areas. It involves qualitative and quantitative methods to analyze drug purity, content, and structure using techniques like chromatography, spectroscopy, and titration. Careful sampling, sample preparation, method selection, data collection and analysis are important factors for obtaining accurate and precise results.

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ismah ibtiha
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151 views

(I) Introduction: Basic Pharmaceutical Analysis

This document provides an introduction to basic pharmaceutical analysis. It discusses key topics including the purpose of pharmaceutical analysis to identify, determine, measure, and understand compounds. Analysis can be used in research, industry, hospitals, and other areas. It involves qualitative and quantitative methods to analyze drug purity, content, and structure using techniques like chromatography, spectroscopy, and titration. Careful sampling, sample preparation, method selection, data collection and analysis are important factors for obtaining accurate and precise results.

Uploaded by

ismah ibtiha
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© © All Rights Reserved
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Download as PDF, TXT or read online on Scribd
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BASIC PHARMACEUTICAL ANALYSIS:

(I) INTRODUCTION

ILMA NUGRAHANI
SCHOOL OF PHARMACY
BANDUNG INSTITUTE OF TECHNOLOGY
2019
INTRODUCTION

1. PURPOSE OF STUDY
 Student can understand the theory and apply the topic in the
analysis works of pharmaceutical compounds.
2. CONTRACT
Student attends at least 80% of total lecturing.
Tolerance of late attendance: 15 min
3. FINAL MARK
Activity in class in consideration 10-20 %
Mid semester test. 40 – 45 %
Final test 40 – 45 %
PHARMACEUTICAL?

 ACTIVE SUBSTANCE
 EXCIPIENT
 FOOD SUPPLEMENT
 COSMETIC APPLICATION
 NUTRIENT
 VETERINARY
 MICRO NUTRIENT
 MACRONUTRIENT
 RESIDU
ANALYSIS?

 To identify
 To determine
 To measure
 To understanding the tendency
Drug and dosage form

SAFETY
EFFICACY

QUALITY
“Pharmacy” > Pharmacon

Drug

Is a xenobiotic, something strange to the body


Drug – medicine :
One or combination of active
compound which used for

• preventive/protective
• diagnosing
• curing/treatment
• rehabilitation
•quality of life enhancement
PHARMACEUTICAL

STRUCTURE SOURCE MATTER

NATURAL
GAS
ORGANIC penicillin – G,
vinkristin,
vinblastin, etc. LIQUID

ANORGANIC SEMI
SYNTHESIS
Al2O3, Mg-
Paracetamol, SOLID
sulfate,
ferifumarat, etc. ibuprofen, etc

SOLID
Combination: SEMI SYNTHESIS
Diclofenac acid, Amoxicillin,
metalo- sulfanilamida,
antibiotic, etc. etc.
DRUG DOSAGE FORM
AREA

 Drug analysis in Background needed


research laboratory
 Pharmaceutical
 Industry science
 Hospital  Chemistry
 Clinical laboratory  Physics
 Forensic analysis  Mathematic and
statistics
 Toxicology
 Skill
 Government
ANALYSIS

PURPOSE METHOD TARGET SAMPLE

IDENTIFICATION PURE MATERIAL/RAW MATERIAL

QUALITATIVE CONVENTIONAL

STRUCTURE PREPARATION/DOSAGE FORM


ELUCIDATION
DRUG
COSMETIC
FOOD
QUANTITATIVE INSTRUMENTAL
SUPPLEMENT
PURITY ENVIRONMENT SAMPLE
WATER
ETC.

SEMI-
ASSAYA/CONTENT
QUANTITATIVE DETERMINATION
ANALYSIS TYPE: PURPOSES

 Qualitative -> identification,


detection of impurity, new structure
elucidation
 Quantitative —> content
determination of bulk/raw material,
dosage form, blood sample,
environment sample, etc.
 Semi quantitative —> impurity
determination, limit test of
metal/impurity
ANALYSIS Type: METHODS

1. Conventional/chemical
- Identification: color test, flame test, agglomeration
test, etc.
- Quantitative: Titration (acid-base, redox,
complexometry, argentometry)
2. Instrumental: can be used for qualitative and
quantitative concurrently —> melting point apparatus,
polarimetry, spectrophotometry, electrochemistry,
chromatography
3. Microbial: antibiotic potency (quantitative)
Pharmacist’s sample

 Drug dosage form


 Blood, urine, and other biological samples.
 Dopping
 Investigational analysis: beverages, stuff around a
suspected case, etc.
Target of analysis

 Identification: to ensure the certain structure of


material
 Elucidation structure: to determine the new structure
 Purity test
 Assay/quantification: measure the concentration 
rendemen, content of dosage form.
SAMPLE:
SUPPLEMENT? COSMETIC?
FOOD? (vs drug)
What the
difference
is?
DRUG SAMPLE

DOSAGE
EXCIPIENT
DRUG FORM
/ACTIVE
SUBSTANCE

Filler (gain the


appropriate weight),
glidan, lubrican,
binder, desintegran,
flavoring agent
solvent, emulgator,
suspending agent,
coloring aggent,
antioxidant,
preservative, etc.
ANALYSIS STAGES

 Method selection
 Sampling: representative, not only one time but in the
several repSample preparation:licate depend on
requirement.
 Sample preparation: crushing, dissolving extraction,
filtering, etc.
 Analysis perform and recording
 Data analysis
 Data presentation
MAN Material and reagent

Methods and
Data
measurement collection,

ANALYSIS
analysis, and
presentation

FACTORS
MAN

 Knowledge and understanding


 Skill
 Integrity and attitude
METHOD SELECTION

 Availibility of tools/instrumentation
 Physicochemical properties of the analyte
 Physicochemical properties of the matrices
 Cost
 Skill of the analyst
 Quality needed: accuracy and precision.
Sample and reagent
preparation

 Depend on the form of samples: liquid, semi solid, solid,


gas?
 Pure/dosage form?
 Kind of matrices?
 Do extraction to isolate the analyte
SAMPLING

 How many sample must be taken


 When
 How to do
 How to storaged
 How to treat —> direct or in-direct?
Analysis

 Tools and instrument preparation


 Material and Reagent preparation
 Direct or indirect?
 How many analysis must be replicated?
 Condition?
 Skill?
DATA ANALYSIS

 No repetition —> No data —> No analysis


 Few data
 Complex data —> need the analysis tools.
DATA PRESENTATION

X +/- SD
SYLABUS
before Mid Test
1. Introduction IN
2. Cation and Anionic Qualitative Analysis IN
3. Functional group and the purity test for
organic drug IN
4. Quantitative Analysis SD
5. Acid-Base Reaction SD
6. Acid base compound and its Salt SD
7. Acid-base reaction non-aqueous SD
8. Mid semester examination IN/SD
Sylabus after Mid Test

1. Complexometry IF
2. Redox titration (1) IF
3. Redox titration (2) IF
4. Nitrimetry TU
5. Argentometry TU
6. Extraction method (1) TU
7. Extraction method (2) TU
8. Final examination IF/TU
References

 Pharmaceutical Analysis, 4th Edition; A Textbook for


Pharmacy Students and Pharmaceutical Chemists,
David Watson, 2016.
 https://getabookweb.wordpress.com/2017/08/20/princ
iples-instrumental-analysis-skoog/
 Fessenden and Fessenden, Organic Chemistry
 ETC.
 Look for in Library : Kimia Farmasi Analisis
others

1. Beckett AH and Stenlake JB, Practical Pharmaceutical Chemistry, 1981

2. Connors, KA, A Textbook of Pharmaceutical Analysis, 1982

3. Departemen Kesehatan Republik Indonesia, Farmakope Indonesia,


edisi IV, 1995

4. Furniss BS, Hannaford AJ, Smith PWG, Tatchell AR, Vogel’s Textbook of
Practical Organic Chemistry, Ed. 5, 1989
5. Jeffery HJ, Basset J, Mendham J, Denney RC, Vogel’s Textbook of Quantitative
Chemical Analysis, Ed. 5, 1989.
6. Mitra, S, Sample Preparation Techniques in Analytical Chemistry, 2003.

7. Pederssen, Ole, Pharmaceutical Chemical Analysis: Methods for Identification


and Limit Tests, 2006.

8. Hahn-Deinstrop E, Applied Thin Layer Chromatography : Best Practice and


Avoidance of Mistakes, Ed. 2, 2007.

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