Evaluation of Quality Control Parameters of Two Brands of Diazepam Tablets

Abstract

Quality is something that characterizes a thing and every company strives for it but often it is very difficult to achieve. Quality of Pharmaceutical Product is very important for achieving the therapeutically active and standard drug. It can be achieved by following some parameters that are specified in the respective monograph of the drug. This research work was aimed to investigate the quality control parameters of two brands of diazepam (Seduxen®, Sedil®) which are available in market. This in turn helps to determine whether the two brands of diazepam were manufactured according to the specifications given by British Pharmacopeia (BP). The two brands of diazepam were collected from local market of Bangladesh. Then the brands were subjected to physical parameter tests such as weight variation, hardness, thickness, friability and disintegration. The brands passed the tests as no tablets cross the ±7.5% weight variation. Average thickness of the Seduxen® was 0.252cm with 0% variation and average thickness of Sedil® was 3.155cm with 0.01% variation for 19 tablets and -0.13% for 1 tablet. Average hardness of Sedil® was greater than 5kg which met the specifications but the hardness of the Seduxen® was not within the compendial limit (5 kilograms minimum and 8 kilograms maximum). Percentage friability of the two brands was not more than 1% and thus they met the specifications. All the six tablets of both the brands disintegrated within 15 minutes and thus they complied with the specifications. Last but not the least it can be concluded that, two brands of diazepam were manufactured according to the specifications given by British Pharmacopeia (BP). Due to some technical problems dissolution and potency test were not performed. So, these two parameters were not compared with compendial limit. But we have done other tests required for the determination of the quality control parameters which have shown satisfactory results.