Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CILNIDIPINE AND VALSARTAN

Pooja J. Parmar*, Ankit B. Chaudhary, Vijay P. Jodhani and Ruchi P. Shah

ABSTRACT

A simple, precise and accurate stability indicating RP-HPLC method has been developed and subsequently validated for the simultaneous estimation of Cilnidipine and Valsartan. The separation was carried out using Inertsil ODS C18 column (150mm x 4.6mm, 5μl), mixture of acetonitrile and water 70:30% v/v with 0.1 ml glacial acetic acid as a mobile phase with a flow rate of 1 ml/min and the effluent was monitored at 230 nm using UV detector. The retention time of Cilnidipine and Valsartan were 5.500min and 2.367 min respectively. The method is linear over the range of 5 - 30 μg/ml and 40-240 μg/ml for Cilnidipine and Valsartan respectively. The method was found to be precise, accurate and specific during the study. The percentage recoveries were found to be 100.23% and 100.87% for Cilnidipine and Valsartan respectively from the synthetic mixture. Cilnidipine and Valsartan were subjected to stress condition to check the degradation behaviour of them. The drugs undergo degradation under acidic, basic, oxidative, thermal and photolytic condition. The proposed method enables rapid quantification and simultaneous analysis of both drugs from synthetic mixture without any interference of excipients. So, the method can be used for routine analysis of Cilnidipine and Valsartan.

Keywords: Cilnidipine, Valsartan, RP-HPLC, Stability indicating.