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.
