Evaluation of the quality control parameters of five different brands of Montelukast (10 mg) tablets available in Bangladesh

Abstract

Treatment of any disease can be failed by prescribing a substandard drug. Nowadays Montelukast is widely used in Bangladesh for the treatment of Prophylaxis and Chronic treatment of Asthma, Acute prevention of Exercise – Induced Bronchoconstriction, Relief of symptoms of Allergic Rhinitis: Seasonal and Perennial Allergic Rhinitis. Therefore, the goal of this study is to evaluate the competitive environment of the local market and evaluate the quality parameters with multiple Montelukast brands. Five chosen brands experimented for physiochemical evaluation and in-vitro evaluation study as per USP. Experimented five brands met the weight variation USP range (differences % ±7.5) and specification of USP Hardness range (4 to 8 or 10 kg). The friability study also matches the USP criteria (mean weight loss ≤ 1%) and disintegration study parameters of BP. Dissolution study were within acceptable criteria according to BP and USP. Only one brand did not match the linearity criteria due to analytical error. Yet the marketed brands in Bangladesh could be prescribed equally as they met USP standard.