Quality control of different brands of Amlodipine tablets available in Iranian market using in-vitro tests based on USP 41

Abstract

Abstract: The present study is a post-market quality control study and examines the physicochemical properties of amlodipine tablet products as domestic and foreign brands available in the Iranian pharmaceutical market. Amlodipine is an antihypertensive drug and is categorized as calcium channel blocker dihydropyridines ,and acts by reducing the amount of calcium in the heart cells and blood vessels wich subsequenty leads to heart rate decrease, dilation of blood vessels and decrease in blood pressure finally, blood flow increases, and the workload of the heart decreases. Aim : Quality control of different brands of Amlodipine tablets available in Iranian market using in-vitro tests based on USP 41 Materials and methods: Four brands of amlodipine tablets, including two foreign and two domestic brands, have been selected and their physicochemical properties have been evaluated in terms of uniformity of dosage units, disintegration test, dissolution, hardness, friability and variation of weight according to USP Pharmacopoeia. ATLC test was performed to check lactose presence in all dosage forms. Result: Indicated that in brands A and D quality control tests including, hardness, dissolution, assay and content uniformity was not acceptable. Brands B and C were acceptable. This findings show the significance continuous quality control. The manufacturing process and the final products for both domestic and foreign brands.

Conclusion: According to the results, not all brands had the required standard in a number of tests, especially the test for hardness, dissulotion and determining the amount of active ingredient; Therefore, it is necessary to review the manufacturing process and formulation for all brands, especially domestic products.