IN VITRO STUDIES OF AMLODIPINE BESYLATE TABLET AND COMPARISON WITH FOREIGN BRAND LEADER IN NEPAL

The aim of this study was to investigate the physicochemical properties of amlodipine besylate tablets. Tablets containing 5 mg of amlodipine besylate were prepared using Generally Regarded as Safe (GRAS) excipients. Preformulation studies were carried out using Fourier Transform Infrared (FTIR) spectroscopy and High Performance Liquid Chromatography (HPLC). Dissolution studies were performed to assess biowaiver criteria for Biopharmaceutical Classification System (BCS) Class I drug. Both the test and reference products conformed to pharmacopoeial requirements for physical parameter of tablets. FTIR studies revealed that there was no interaction between drug and excipients used in the test product. The percentage of drug remaining in the samples, subjected to the accelerated condition, complied the range specified in the United States Pharmacopeia (USP) monograph of amlodipine besylate. The dissolution of both the products was found to be more than 85 % in pH 1.2 buffer at the interval of 15 min. However, in pH 4.5 and pH 6.8 buffer media, only test product released more than 85 % drug, whereas the reference product did not.  Mathematical analysis suggested that the release profiles obtained from the test and reference products in pH 4.5 and pH 6.8 buffer media were dissimilar. The finding of this study suggests that, under the tested conditions, the test product is better than the leading foreign brand available in Nepal. Prescribing pattern could be tailored based on the pharmaceutical quality of the product as well as cost of therapy to ensure better pharmacotherapy and patient compliance