Comparative study of quality control parameters of different brands of oral montelikast tablets available in Bangladesh

Abstract

Quality control of pharmaceutical product emphasizes on various testing of the product which include both in-process and finished product quality control tests that are conducted prior to release of the drug in the market. In the present study the quality control parameters of ten different brands of Montelukast tablets available in Bangladesh were evaluated and compared to assess the quality of the tablets. The samples of the tablets were taken from five leading pharmaceutical companies of Bangladesh represented as A to E respectively, three medium ranked companies designated as F, G, H and two low ranked companies denoted as I and J respectively. Quality control tests such as weight variation, friability, hardness as well as disintegration tests were performed. In vitro dissolution study was carried out and analyzed by HPLC to determine the percentage release of drug after 30 minutes which may reflect in vivo performance of the drug. The weight variation results show that there was hardly any variation among the leading pharmaceutical companies (value ranging 0.17±0.01 gm to 0.2±0.01 gm) except for company B (0.35±0.01 gm) and the middle and lower ranked company showed slightly higher results. The tablets of all the ten companies showed acceptable values of hardness except for one low-ranked company J with a high value of 16.57±1.4 kg/cm2. There is a marginal difference in the result of the friability test of the all the ten companies (all values less than 1% according to BP specification), signifying that the Montelukast tablets produced by the different companies of Bangladesh have sufficient mechanical strength to withstand the pressure due to processing, storage and shipment. Disintegration times of the tablets of leading companies were found to be within 3 minutes indicating a very good result except for company A (7.40±0.9 minutes). Company F and company I showed the highest disintegration times (9.4±1.17 minutes and 9.8±3.6 minutes respectively). Consequently, the percentage release of drug for company A, company F and company I are less compared to other companies as shown by the dissolution study. Nevertheless, all the companies showed greater than 90% dissolution of drug after 30 minutes, thus complying with the specifications of British Pharmacopeia and US FDA guidelines for INN drugs. Hence, it can be concluded that Montelukast tablets produced by the pharmaceutical companies in Bangladesh are of consistent quality with very little variation among them and complies with the specifications of British Pharmacopeia.