ULTRAVIOLET SPECTROPHOTOMETRIC EVALUATION OF DIFFERENT BRANDS OF AZITHROMYCIN DIHYDRATE TABLETS AND CAPSULES SOLD IN NIGERIA.

Ukwueze S. E.*, Nwachukwu I. P. and Ezealisiji K. M.

ABSTRACT

The aim of this study was to carry out a spectrophotometric and other pharmaceutical quality evaluation of different brands of azithromycin dihydrate tablets and capsules from Nigerian markets and to predict their bioequivalence using in vitro dissolution tests. The evaluation was done by carrying out tests such as weight uniformity, friability, active drug content, disintegration and dissolution tests using standard procedures. The similarity factor was determined for the brands. All the brands complied with the weight uniformity test, friability (brands AZ1-AZ9) and active drug content test. All brands (except AZ8) complied with the official specification for disintegration time test with no disintegration at T30 and dissolution test with T30 less than 85%. With dissolution profile of 85% within 15 minutes for samples AZ1. AZ8 displayed very low dissolution rate, which would likely result in poor bioavailability. From the results of the bioequivalence determination, all the tested brands (except AZ-8) could be said to be bioequivalent with the innovator brand (AZ9) and thus interchangeable. The similarity factor (F2) value for sample AZ8 was determined to be 10.7, suggesting that (AZ8) was not bioequivalent with the innovator product as its F2 value fell outside the acceptable standard. In conclusion, the results of the study showed that there is the need for constant monitoring of different brands of azithromycin introduced into the drug market to ascertain bioequivalence and conformity with pharmacopoeia standards.

Keywords: Azithromycin dihydrate, Tablets, Capsules, Comparative study, Bioequivalence.