Comparative In Vitro Quality Evaluation of Brands of Propranolol Tablet Marketed in Okada, Edo State, Nigeria.

Abstract

Propranolol, a beta-blocker is used in the management of cardiovascular conditions such as irregular heart rate and high blood pressure. The study was carried out to examine the in vitro quality control tests for seven brands of propranolol hydrochloride 40 mg tablet formulation, sold in retail pharmacies in Okada, EdoState, Nigeria. The parameters determined were identification, weight variation, friability, hardness, disintegration, dissolution rate, and assay of the tablets. The tablets were evaluated for conformity with British Pharmacopoeia (BP) standards. Results obtained showed tablet weight in the range of 155.63.2 mg to 348.22.0mg, hardness ranged from 1.03 0.17to 10.70 0.90 kg/cm2, friability of < 1 % except for one brand, disintegration time of 1.37 0.15 to 18.05 2.88 min whereby two brands are uncoated tablets and assay of 90.07 1.15 to 102 1.62% with one brand deviating from the specified limit. The seven batches also released more than 80% of their drug content within 30min. Analysis of similarity factor revealed that all brands but PN-7 can be interchangeable with PN-1 in terms of dissolution profile. The study showed that propranolol samples examined passed all the Pharmacopoeial tests for satisfactory quality except PN-6 which did not comply with most of the Pharmacopoeial specifications. Thus, not all brands can be used interchangeably in clinical practice. Keywords: Propranolol; Quality Control; Dissolution; Pharmacopoeial specifications