DEVELOPMENT OF HPLC-PDA METHOD FOR QUANTIFYING AMLODIPINE BESYLATE IN TABLETS

Abstract

Cardiovascular disease is a dangerous disease known to be the leading cause of death globally, and hypertension is considered one of the main risk factors contributing to the disease. Among the high blood pressure medications currently on the market, amlodipine besylate is a commonly used drug to treat high blood pressure and prevent related diseases. This study aims to develop a procedure for the quantification of amlodipine besylate in tablets and drug quality control methods, using highperformance liquid chromatography. The method used in this research was high-performance liquid chromatography (HPLC) combined with a photodiode aray detector (PDA) and then was subsequently evaluated according to the guidelines of the International Conference on Harmonization (ICH). Research results successfully developed a process for quantifying amlodipine besylate in tablets with specificity, linearity with a linear range from 8 to 32 µg/mL, high accuracy, high precision, and a short analysis time (5 minutes) that meets the requirements of the quantification process in drug testing and can be applied to check the quality of amlodipine drugs on the market.