Quality assessment of five pharmaceutical products of different brands marketed in Nigeria

Abstract

Many pharmaceutical products have been reported to be substandard and counterfeit. About 15% of all drugs circulating in some parts of Africa and Asia are believed to be counterfeit, with figures rising to as high as 50%. This study was therefore carried out to assess the quality of five groups of drugs of different brands manufactured by pharmaceutical companies in Nigeria. Qualitative and quantitative analysis were carried out on the drugs using United States, British and Indian Pharmacopoeias. Qualitative analysis investigated includes: friability test, hardness test, disintegration test, dissolution test, pH, and weight uniformity for tablets; specific gravity, flow rate, pH and weight per ml of syrups. The quantitative analysis includes percentage purity and drug assay determination for different constituents using titrimetric, spectrophotometric and high performance liquid chromatographic (HPLC) methods. From the study, it was established that the Nigeria brands of pharmaceutical products sampled generally conformed to the established qualitative and quantitative specifications. There was however a short slight fall in the chromatographic assay for vitamin B6 in the Blood tonic from one company and similarly, the vitamin B1 in the Blood tonic of one company were at variance to those from other companies. The result for the statistical analysis shows that there is uniformity in weight of all tablets analysed and it complies with the specification. Standard pharmaceutical analysis must therefore be regularly carried out on pharmaceutical products before marketing so as to ensure good health, safety, elimination of sub-standard drugs and prevention of over- or under-dosage, which may further affect or cause damage to the health of the users. Consumer’s choice of generics should therefore be based on the analytical results (assay results, bio-pharmaceutical results, and statistical results) of the product and the projected bioequivalence.