Nigerian Journal of Animal Science and Technology

Nig. J. Anim. Sci. Tech. Vol. 1 (2):118 - 124

Available @ www.unimaid.edu.ng
© Department of Animal Science, University of Maiduguri
NJAST
Assessing the Quality of Selected Veterinary Drugs in Nigerian Markets
*
Shamaki, B.U1., Salihu, S.I1., Daniel, N1., Garta, K. M1., Gwary, O. M2., Chabiri, A. S2 and
Chamba, G.2.
1
Department of Veterinary Pharmacology and Toxicology, Faculty of Veterinary Medicine, PMB 1069,
University of Maiduguri, Bama Road, Maiduguri. Borno State, Nigeria
2
National Agency for Food and Drug Administration and Control (NAFDAC), Maiduguri Area Laboratory,
Maiduguri, Borno State, Nigeria
Abstract
The study was conducted to assess the quality of selected, commonly used Veterinary drugs in
Nigerian markets. These drugs include oxytetracycline, Vetcotrim (containing both sulphadiazine
and trimethprim), Recapen fortified procaine penicillin and albendazole bolus. The samples were
collected randomly using simple random sampling. The drugs were analyzed using UV-VIS
spectrophotometric technique. The results of the analysis showed that the content of their
pharmaceutically active ingredients when compared to the various manufacturers claim were
found to be as follows; Oxytetracycline, 205. 8 mg was obtained against the manufacturer’s claim
of 200 mg (102.9 %), Vetcotrim-sulphadiazine 205.6 mg was obtained against 200 mg (102.8 %),
Vetcotrim-trimethoprim 371.2 mg was obtained against 400 mg (92.8 %); Fortified procaine
penicillin 702.6 mg was obtained against 600 mg (117.1 %) and Albendazole bolus 231.5 mg was
obtained against 250 mg (96.6 %). This study showed that the content of various active principles
in the drugs analyzed are within the permitted pharmaceutical (USP/BP) standard limits of 95-
105 % for oxytetracycline, at p<0.05 and sulphadiazine 90-110 % at p<0.01 for trimethoprim and
albendazole, except procaine penicillin which fell short of the active principle content but was
within the permitted pharmacopeia (USP/BP) standard limit of 90-110 % (p <0.01 and as claimed
by the manufacturers. This finding indicates that the veterinary drugs under study are safe and
can be used for treatment of diseases in animals, except Procaine penicillin that fall short of its
standard, and will need to be evaluated for that, in ensuring safety in animals.
Keywords: Veterinary, Drugs, quality, safety, adverse reaction, resistance, Nigerian.

Introduction failures on the field (Olatoye and Saraye, 2012)

Substandard products with lower than stated necessitated this study.
doses mislead clinicians and promote resistance
and those containing no antimicrobial active Veterinary drugs in animals can be used for
principle promote microbial dissemination various purposes such as therapeutic and
(AVMA/NMPF, 1999). The proliferation of prophylactic agents (Hirsh and Zee 1999),
fake or substandard drugs could contribute to growth promotion and other uses (Kannene and
wide spread resistance to numerous antibiotics Miller 1997, Castanon, 2007). When veterinary
with tetracycline resistance being one of the drugs are indicated rationally in right dose and
most commonly reported (Shakoor et al., route of administration, the potential damages
1997). There is a larger market for veterinary of its use is reduced and their efficacy increased
drugs in Nigeria with about 130 existing (Victomir, et al, 2011), rational use of drugs in
pharmaceutical manufacturers and importers veterinary medicine has both economic and
involved in the production and packaging of public health significance (FAO, O/E/WHO,
veterinary drugs and reports of obvious therapy 2003). World Health Organization, (2011)

Email: [email protected] Phone: +234 8065524181, +234 8025674228

 Shamaki et al. 2018

reported that non rational use of veterinary development by hitherto, susceptible

drugs as well as the need for control of their use microorganisms (Shakoor, et al., 1997). There
becomes even bigger problem when used on is a larger market for drugs in Nigeria with
food producing animals (Victomir et al., 2011). about 130 existing pharmaceutical
The irrational antimicrobial use raise particular manufacturers. Only 60 out of these are
concern for residues in food of animal origin manufactured, the rest are imported (Sirdar et
and for the development of antimicrobial al., 2012, Olatoye and Saraye, 2012, Omeiza
resistance (Adesokan et al., 2014). To maintain and Nafrnda, 2015).
the efficiency of antibiotics and to reduce the
risk of resistance bacteria development, the use This work is aimed at assessing the quality of
of antibiotics must be controlled. Maintaining selected commonly used Veterinary drugs in
all food animals in a clean healthy environment, Nigerian markets and evaluation of the
and developing a nutritional program to meet concentrations of their manufacturers claimed
growth maintenance and lactation needs of formulations.
animals are crucial, hence misuse of drugs is
best avoided by implementing management Materials and method
practices and health programmes that keep The materials used for the analysis include;
animals healthy and producing efficiently. On Digital weighing balance, conical flask,
the other side, increase in amounts of active UV/VIS spectrophotometer, ultrasonic
principles in a drug can lead to cumulative machine, test tube, pipette, spatula, volumetric
effects and adverse drug reactions (Chepra and flask, ultrasonic sonicator, centrifuge machine
Roberts, 2001, Pedros et al., 2014). and digital pH meter (all from Germany). The
drugs are oxytetraccycline 200 mg,
In Nigeria, like in most developing countries, Sulphadiazine 200 mg, Trimethoprim 400 mg,
antibiotics are widely available over the counter Albendazole bolus 250 mg, fortified procaine
and mostly used without prescription penicllin (Benzyl penicillin 600 mg) from
(Ezenduka et al., 2011). Withdrawal periods are different companies.
not usually observed and residues of drugs in Assessment of Oxytetracycline, Sulphadiazine,
food animals and their by-products have been Trimethoprim, Procaine penicillin and
reported (Kabir et al., 2004). Several brands of Albendazole were determined by adopted
tetracycline are imported and sold in Veterinary method of Radostis (1974).
shops, livestock markets drugs peddlers, and
are routinely used by farmers without Sample collection
Veterinary diagnosis and prescription The samples of the test drugs were purchased
(Fagbamila et al., 2010), and most of these from Veterinary shops along kasuwan shanu
drug formulations have been reported to be markets in Maiduguri, Borno State. The
ineffective against tetracycline susceptible samples were collected randomly using simple
organisms (Ogunleye et al., 2013). World random sampling.
health organization (2011), estimated that about
30 % of medicines sold in African markets are Sample preparation
counterfeit of which antimicrobial agents is the Average weight of 10 tablets for each of the
most reported. Substandard products with samples were taken using analytical weighing
lower than stated active principles, promote balance and equivalent weight of 25 mg for
resistance (Okeke et al., 2007). The each sample was collected and transferred to
proliferation of fake or substandard drugs could 100 ml volumetric flask. It was dissolved in 50
contribute to widespread resistance ml of the solvent and sonicated and allowed to

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equilibrate for 10 minutes, it was then made up 100 ml volumetric flask and filled to mark, and
to volume with distilled water and the it was sonicated for 5 minutes, further dilution
absorbance was determined at 353 nm. of 1 ml in 10 ml of the solution was made twice
and ultraviolet absorbance was read twice at
Assay of albendazole was done by adding 50 ml 252 nm taking E 1 %, 1 cm = 6.0 using 0.1 N
of methanol in a 100 ml volumetric flask and 2 sodium hydroxide as diluents.
ml of Hcl was diluted to volume and mixed with
standard solution, 90 mg of Albendazole was Results
accurately weighed and added to 250 ml The results of the analysis is presented in Table
volumetric flask, 10 ml of acidified methanol 1. It showed that Oxytetracycline had the
was added and shaken to dissolve. It was then highest concentration of active ingredients with
diluted with 0.1 N HCl to volume and mix, 102.9 %, and is the most abundant drug in the
another 5.0 ml of this solution was transferred Nigerian market, and has the highest
to a 200 ml volumetric flask and diluted with concentration of 200 mg, followed by
0.1N NaOH to volume and mixed. Similar Vetcotrim (sulphadiazine) which had 102.8 %
assay was adapted for trimethoprim evaluation. and a concentration of 205.6 mg.

Trimethoprim was assayed by weighing 20 Sulphadiazine content in vetcotrim in this study

tablets, and its powder containing 100 mg was 205.6 mg equivalent to 102.8 % as against
equivalent weight was added to 100 ml of the manufacturer’s claim of 200 mg (95-105
glacial acetic acid, it was shaken for 20 minutes, %). This showed that both manufacturers’
then diluted with 200 ml glacial acetic acid and claims were within the recommended range.
100 ml of distilled water was added. The
absorbance of the resulting solution was The trimethoprim content of vetcotrim is said to
measured at maximum of 271 nm. be 400 mg according to the manufacturers,
while the result obtained in this study showed
Assay for sulphadiazine was also done by 371.1 mg of active trimethoprim equivalent to
ultraviolet absorption method, in 1.0 N 92.8 %, this showed that the manufacturers’
hydrochloric acid maximum at 242 nm (E 1 %, claims and results obtained were within the
1 cm = 597) in 0.1 hydrochloride maximum at recommended range (90-110 %).
240 nm (E1 % 1 cm = 866) and 254 nm (E 1 %
1 cm = 866) in Alcohol (95 %) maximum at 274 Albendazole had 96.6% presence in the
nm E 1 % 844). It was weighed equivalent of Nigerian markets; it had a concentration of 250
12.5 mg was weighed from powdered 20 mg as claimed by the manufactures. Fortified
tablets, an addition of 30 ml of sodium procaine penicillin had the highest
hydroxide was made and the mixture shaken for concentration (702 mg) in the Nigerian markets
30 minutes using ultrasonic bath it was then as against the manufacturers claim of 600 mg of
made to 50 ml mark volumetric flask, 1 ml of the active ingredient.
the stock solution was diluted in 10 ml of
distilled water in a test tube and the absorbance The results of this study showed that these
read at 240 nm, taking E 1 % 1 cm = 876). drugs are available in the Nigerian markets with
different concentration based on their use and
Benzyl penicillin was assayed by using a vial of demand. Fortified procaine penicillin (Benzyl
fortified procaine penicillin which was penicillin) was the only drugs that failed the
reconstituted with 8 ml of distilled water, 1.3 ml manufacturers claimed percentage levels and
of the content was pipetted and transferred into milligram concentrations of the drugs. This

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may be due to some factors like environmental improper measurement and manufacturing
elements, transportation, improper storage, shortcomings.

Table 1: The concentrations and percentage levels of active ingredients contained in the drugs
Name of drugs Conc. (mg) Std range (%) Results mg (%)
Oxytetracycline 200 - 205.6 95-105 (102.9)
Vetcotrim 200 95-105 205.6 (102.8)
(sulphadiazine)
Vetcotrim 400 90-110 371.2 (92.8)
(trimethoprim)
Fortified procaine 600 95-105 702.6 (117.1)
Penicillin
Albendazole 250 90-110 241.5 (96.6)

Discussion claim and the findings in this study. This is in

The results of this study showed that line with the findings of Jibike et al, (2015) who
oxytetracycline is the most widely used reported that chemical evaluation of some
antibiotic in the poultry industry, which different brands of 5 % oxytetracycline
corroborates the findings of Kantiyok and antibiotics in the Nigerian markets
Arowolo (2015), Bosha and Onyeyili (2016) demonstrated significant difference of pH and
who both reported that 75.97 % and 38.5 % use specific gravity within batches and brands. In
of this particular antibiotics in veterinary another study by Jibike et al (2016), and this
practice indicating highest concentration of this may have effects on the efficacy of the drug. It
drug in the Nigerian market. In this study, was reported that several brands of tetracycline
oxytetracycline has 102.9%, followed by imported and sold in Veterinary shops,
vetcotrim (sulphadoxime) 102.8 % livestock markets and by drugs peddlers are
respectively. The abundance and ready routinely used by farmers without Veterinary
availability of this drug made it routinely diagnosis and prescription, adding to the misuse
abused in veterinary practice, leading to misuse and resistance development. This significant
in feeds to promote growth and production, and difference in both physical and chemical
also extra label use. This may lead to composition may lead to ineffectiveness, and
development of antimicrobial resistance by other unwanted therapeutic effects of the drug
hitherto, susceptible bacterial organisms, when use as reported by Fagbamila et al.,
which are reported to cause a lot of losses to (2010). Most of these drug formulations have
poultry and livestock industry in Nigeria, with been reported ineffective against tetracycline
attendant discouragement of many potential susceptible organisms, and this can lead to
farmers (Ogunleye et al., 2013, Kantiyok and reverse zoonosis of humans to animals as
Arowolo, 2015). reported by Umaru et al (2013).

Another factor that may be responsible for Albendazole has the dose of 250 mg active
ineffectiveness of antibiotic therapy is the principle as claimed by the manufacturers,
difference in concentration of active ingredients however results from this work has shown that
as claimed by the manufacturers. The result of it has 241.5 mg active principle, 8.5 mg less of
this study showed that there is a significant the manufacturers claim. The pharmacological
(p<0.05) difference between the manufacturers’ implication of this is that appropriate dosing

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may be compromised and not adhered to and under dosing per body weight of an animal
sometimes whole drug administration may not when treated with such drug, thereby
be complete hence, less the actual amount that predisposing the animal to drug resistance
can give maximum therapeutic value per development.
kilogram weight of the animal. This trend can .
predispose prevalence of gastrointestinal Conclusion
helminthes in animals resulting to risk of It can be concluded that there exists
exposure of animal owners to zoonotic discrepancies in concentrations of active
infections (Idika et al., 2016), this is in principles contained in some drugs in Nigerian
agreement with findings of Odeniran et al markets, and in addition to other factors, (such
(2013) who reported zoonotic infections by as transportation, environmental temperature,
helminthes are among the most common on improper measurement, improper storage of the
earth, and are responsible for > 60 % human drugs, poor record history of a herd and poor
infectious diseases. Fortified procaine advice, and inappropriate dosing of drugs by
penicillin has the highest of 117.1 % in the Veterinarians), as reported by Muhammad et al
Nigerian market and frequently used in (2015) may be responsible for drug resistance
veterinary practice. Findings from this study development by microbes, and other residual
showed that fortified procaine penicillin effect in tissues of animal, which is of public
(Benzyl penicillin) is one of the drugs that health significance. Therefore, provides the
failed the standard test with actual basis of the importance of awareness of
concentration at variance with the National Veterinary Drug use for safety, its
manufacturer’s claim of milligram public health and economic significance and the
concentration of the drug. This corroborated enforcement of control measures of National
with the findings of (Dipeolu, 2002). Veterinary Drugs use in food of animal origin
by the regulatory agencies..
Vetcotrim (sulphadiazine) in this study has 200
mg within the range of (95-105) % according to Recommendation
manufacturer’s claim, while the result obtained Based on the findings of this study, it is
in this study was 205.6 mg (102.8%), although recommended that veterinary workers should
within percentage range, an increase of 5.6 mg use those drugs that are found to be of standard
away from the appropriate weight dose in an preparation, especially in diseases caused by
animal can cause serious consequences in susceptible parasites, and to be pharmaco-
treated animals, and can predispose the patient vigilant in terms of adverse drug reactions,
to adverse drug reactions, and if such animals especially after use of those drugs with
treated is slaughtered, residual effects of such discrepancies in concentrations of active
drug may be experienced in the consumers. The principles. It is also recommended that more
same was observed with Vetcotrim analysis should be conducted on Procaine
(trimethoprim) which has 400 mg and a penicillin (Benzyl penicillin) which shows high
percentage range of (90-110) % as claimed by variation compared to the manufacturers claim.
the manufacturers, however, the result obtained
in this study showed that it only contain 371.2 Acknowledgements
mg of the active principle, thus, 28.8 mg less of The authors wish to thank the Management of
the claimed active principles. This shows that NAFDAC for technical assistance and
the manufacturers claims and result obtained permission for the work to be carried out in
were not in agreement, but within the their laboratory in Maiduguri.
percentage range. The implication of this is

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