Stability Indicating Assay Method Development and Validation of Amlodipine Besylate in Bulk and Tablet Dosage form by UV Spectroscopy and RP-HPLC

Abstract

A simple, cost effective, highly precise and robust stability indicating UV Spectroscopy and RP-HPLC method was developed for the estimation of Amlodipine in bulk and tablet dosage form. The chromatographic separation was achieved on Agilent C18 (250mm×4.6mm, 5µm) with mobile phase methanol: water in the ratio of 80:20 v/v with flow rate of 1ml/min at detection wavelength 238nm using Photodiode array detector. The method was validated for linearity, precision, accuracy, LOD, LOQ and robustness. The linearity range by UV Spectroscopy was found to be 10-30µg/ml and by RP-HPLC method was found to be 10-50µg/ml with correlation coefficient of 0.999 for both the methods. The relative standard deviation values for precision, accuracy and robustness were less than 2%. The LOD was found to be 1.84µg/ml and 1.56µg/ml for UV Spectroscopy and RP-HPLC method respectively. The LOQ was found to be 5.59µg/ml and 4.81µg/ml for UV Spectroscopy and RP-HPLC method respectively. Amlodipine was subjected to stress conditions of degradation including acid degradation, alkaline degradation, Oxidation, photolysis and thermal degradation. The method is simple, reliable, sensitive and precise which could separate the drug and their degraded product under various stress conditions, thus it can be employed as stability indicating method for the determination of Amlodipine in bulk and tablet dosage form.