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Abstract

COMPARATIVE STUDY OF THE QUALITY OF SOME BRANDS OF DIAZEPAM TABLETS AVAILABLE IN NIGERIA

Ukwueze S. E.*, Nkangwung M. J. and Odigie J.

ABSTRACT

Quality assurance and control of pharmaceutical products is very important for achieving a therapeutically active and standard product. This can be achieved by monitoring some parameters that are specified in the monograph of the drug or product .This study was aimed at evaluating the pharmaceutical profile of different brands of diazepam available in some Nigerian markets. These brands of diazepam were subjected to official tests as specified in USP and BP. The tests were weight uniformity, disintegration, friability, dissolution and crushing strength/hardness test. The content of active ingredient was determined using the U.V visible spectrophotometer at a maximum wavelength of 302 nm. Beer’s law was obeyed at a concentration range of 0.2-1.2 µg/ml. The result showed that all the brands of diazepam analyzed passed disintegration, friability and weight uniformity test except D1.Only two brands of diazepam D2 & D3 passed content of uniformity test. Also, all brands of diazepam analyzed passed dissolution test. Fit factor (F2) was calculated according to FDA which was used to determine bioequivalence of the brands with the innovator brand. Although all the brands analyzed had F2 values greater than 50, and hence could be used interchangeably with the innovator brand, the non-conformity of the diazepam generics to some of the quality control test standards called for caution in their substitution clinically.

Keywords: Comparative quality study, Diazepam, Nigerian markets, innovator brands, bioequivalence.


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