Published Paper Details:

Simple, specific, accurate, precise and reproducible and robust method have been developed and validated for the Simultaneous Estimation of Azelnidipine and Chlorthalidone in tablet Dosage from. The Reverse Phase High Performance Liquid Chromatography, the chromatographic system was equipped with Kromasil C18 column (150 x 4.6 x 5 �m) and UV detector set at 235 nm, in conjunction with a mobile phase of 20 mM diammonium hydrogen phosphate and Methanol in the ratio of 65:35% v/v (Gradient) (pH 5.5, adjusted with 1% orthophosphoric acid) at a flow rate of 1.2 mL/min. The described method was linear over a concentration range of 40.39-121.16 �g/ml for Azelnidipine and 31.16-93.47 �g/ml for Chlorthalidone. Retention time of Azelnidipine and Chlorthalidone were found to be 10.414 and 4.616 min respectively. The %Recoveries of Azelnidipine and Chlorthalidone at the three different levels were found in the range of 98.9-101.6 % and 99.3-100.9 % respectively. Methods were statistically validated for accuracy, precision, specificity, LOD, LOQ and robustness according to ICH guidelines and can be used for analysis of combined tablet formulation. Azelnidipine and Chlorthalidone were subjected to stress conditions of acid degradation, base degradation, oxidative degradation and thermal degradation under same chromatographic condition. The stress samples were assayed on RP-HPLC system.