Comparative Quality Control Evaluation of Atenolol Tablets Marketed in Kuala Lumpur, Malaysia.

ABSTRACT

Background: The emergent of many pharmaceutical companies producing their own generic type of drugs after the patent of innovator drugs expired can improve the general healthcare delivery systems as well as decreasing the healthcare costs. But it also raises a few issues with one of it is the widespread of substandard and counterfeit product. Postsurveillance study to assess product parameter of various generics drug marketed is crucial. This kind of monitoring reduces a country’s economical burden on health issues from diseases due to fraudulent and substandard drugs usage. Purpose: The main objective of this study is to perform a comparative evaluation of the physicochemical properties of five commercially available leading brands of Atenolol tablets marketed in Kuala Lumpur. Method: The quality control parameters of five different brands of atenolol tablets were atenolol tablet assessed included uniformity of content, uniformity of weight, friability, crushing strength, disintegration and dissolution tests as well as content uniformity of the tablets. All the tablets were assessed for conformity with British Pharmacopoeia (BP) standards. Results: All the five brands of the tablets passed the British Pharmacopoeia (BP) standards for weight uniformity, disintegration, friability, content uniformity and hardness tests. Conclusion: The quality control parameters of all five top selling brands of atenolol tablets marketed in Kuala Lumpur analyzed passed all the BP and USP quality specifications and were physically and chemically equivalent.