ISSN 2326-7267
International Journal of Pharmacy and Pharmacology Vol. 1 (1) pp. 001-007, October, 2012. © International Scholars Journals
Full Length Research Paper
Quality of brands of atorvastatin calcium tablets marketed in Lagos, Nigeria
Moshood O. Akinleye1, Oladipo Idris2*, Patricia N. Nwachukwu1 and Olubukola O. Oyetunde3
1Department of Pharmaceutical Chemistry, Faculty of Pharmacy, College of Medicine, University of Lagos, Idi-araba, Lagos, Nigeria.
2Department of Family Medicine, Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria.
3Department of Clinical and Biopharmacy, Faculty of Pharmacy, College of Medicine, University of Lagos, Idi-araba, Lagos, Nigeria.
*Corresponding author. E-mail: [email protected]
Received 08 September, 2012; Accepted 03 October, 2012
Abstract
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.
Key words: Atorvastatin, in-vitro bioequivalence, switch ability, quality, safety.