Abstract

Akinleye MO, Idris O, Nwachukwu PN and Oyetunde OO

This study investigated the quality of atorvastatin calcium tablets marketed in Lagos, Nigeria, by evaluating and comparing their physico-chemical profiles. Evaluation of physico-chemical parameters viz: uniformity of weight, hardness, friability and disintegration test was carried out according to British Pharmacopoeia. Assay of active ingredient and in-vitro dissolution evaluation were conducted using USP Apparatus 2 satisfying the general conditions for film tablets as stipulated in official books. Tablets and dissolution samples were analyzed using a modification of the validated High performance liquid chromatographic method developed by Stanisz and Lukas. All the three brands met the standards for the physical qualities of a satisfactory tablet, and all had percentage purities within the 90 to 110% range. Only brands AT and CT had released ≥75% of label claim of atorvastatin calcium within 45 min, as specified in the B.P for conventional tablets. Thus, brand BT which had barely released 70% of its label claim at 60 min failed dissolution test. We concluded that out of the 3 brands of immediate-release atorvastatin calcium tablets available in the market at the time of the study, only 2 passed all the pharmacopoeia tests for satisfactory quality. Thus, only these can be interchanged in clinical practice.