Evaluation of the Quality Control Parameters of Two Different Brands of Combined Atenolol (50mg) & Amlodipine (5mg) Tablets Available in Bangladesh

Abstract

Hypertension is a very common disease. To treat this disease in short possible time combination drugs came in the market, because these are more efficacious and have low side effects. Amlodipine and Atenolol combination is widely used in Bangladesh for hypertension treatment. So quality control studies are performed in different marketed products in Bangladesh. The main objective of this study was to perform a comparative evaluation of the quality control parameters of two commercially available brands of combined atenolol (50mg) & amlodipine (5mg) tablets marketed by local pharmaceutical companies. Tablets from four batches of Camlodin® Plus and Amlovas® AT met the specification of USP for weight variation and thickness test. In hardness evaluation all four batches of two brands showed lower value than the specified range (4 to 8 or 10 kg). For disintegration test all batches met the specification of BP. In potency determining test for Amlodipine, only Batch-SGJ52 of Amlovas® AT (86%) did not met the specified range (90 to 110%) of BP. But in case of Atenolol all batches of two brand met the specification of BP. In dissolution study all batch of two brands met the specification of BP. Hardness and Potency of some batch did not met the specification due to formulation, processing or analytical error. Due to technical problem friability study could not be done. Further study needs to be conducted regarding the quality control parameters as these products are now becoming a potential choice of drugs for hypertension control.