Validation of a SpectrophotometricMethod for Amlodipine Besylate in a Tablet Form

Abstract

The main objective of this work was to develop a new method for quantitative determination of Amlodipine in tabletpharmaceutical dosage Formby UV Spectrometry. The method was based on measuring the absorbance value of Amlodipine besylate at 237nm wavelength, using a mixture of methanol, acetonitrile, buffer solution (35:15:50) as a solvent. A sample of drug was dissolved in the mixture. The method for the quantitative determination of Amlodipinein tablet formconformed with the requirements of the ICH guidelines for the main validation parameters: selectivity, accuracy, linearity, Sensitivity,Precisionandrobustness. The results obtained in study clearly indicated that the developed UV Spectrometry method was fast, economical, simple, accurate and suitable for determination of Amlodipine in tablet form.