Quality Control Assessment of Five Brands of Ketoconazole Tablets Marketed in Nigeria

Abstract

The qualities of five different brands of ketoconazole tablets commercially available in Nigeria were assessed. The weight uniformity, hardness, friability, disintegration time, absolute drug content and dissolution rate of the brands were determined using official or standard methods, as applicable. The five brands passed the uniformity of weight test with the range of 0.351 – 0.676 g, hardness test with a range of 4.00 – 7.70 kgF, friability test with a range of 0.146 – 0.268 % and absolute drug content with a range of 98.82 – 107.02 % and conformed to the pharmacopoeias specifications. However, all the tested brands had poor dissolution profiles. None of the brands was bioequivalent with the innovator brand.

Keywords: Ketoconazole tablets, quality control, interchangeability, Nigeria

Nigerian Journal of Pharmaceutical Research, Vol. 9 No 1 pp. 15 - 22 (February 2011)