Abstract

DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF LERCANIDIPINE AND VALSARTAN IN SYNTHETIC MIXTURE

Sapna M. Patel*, Pooja Patel and Dr. Dilip G. Maheshwari

Abstract

A simple, sensitive, accurate, precise first order derivative Spectrophotometric method was developed and validated for the determination of Lercanidipine and Valsartan in Synthetic Mixture. In The first order derivative method absorption at 235 nm (zero crossing point of Lercanidipine) was used for measurement of Valsartan and 244 nm (zero crossing point of Valsartan) was used for measurement of Lercanidipine. The linearity was taken in the concentration range of 1-6 μg/ml for Lercanidipine and 8-48 μg/ml for Valsartan with correlation coefficient (R2) 0.999 for both the drugs. The developed method was validated according to ICH (Q2 R1) guidelines and whereby %RSD values were found to be ˂2% complying the validation requirements. Method can be applied to the simultaneous estimation of Lercanidipine and Valsartan in their Synthetic Mixture. The results of analysis have been validated statistically and by recovery studies.

Keywords: Lercanidipine, Valsartan, First order derivative, Synthetic Mixture, Validation method.