Quality Control Testing and Equivalence of Doxycycline Hyclate (100 mg) Capsule Brands under Biowaiver Conditions

Abstract

The study aimed to compare dissolution profiles of five generics of a BCS class I drug (Doxycycline Hyclate) with innovator Doxycycline Hyclate and also to compare the quality of different brands of Doxycycline Hyclate 100 mg capsules, collected from various retail pharmacies in the local market of Pakistan under biowaiver conditions. Assessment of physical parameters which include uniformity of weight and disintegration test was done according to British Pharmacopeia (BP) 2007 requirements. Chemical assay was carried out using a validated UV spectrophotometric method.