DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF LERCANIDIPINE IN BIOLOGICAL MATRICES

A simple, precise, accurate, reproducible and robust analytical method was developed using reversed phase HPLC for quantitative estimation of lercanidipine in biological matrices. The method was validated as per the ICH and FDA guidelines. Analysis of the drug was performed in an is ocratic mode employing methanol and acetonitrile (74:26) as the mobile phase on a C18 column. UV-Visible detector at 219 nm was found to be suitable for drug estimation. Linearity was observed in the range of 5 and 500 ng/mL(p<0.001). Recovery was found to range between 96.26% and 100.67%. The %RSD values for method precision and system precision were found to be 0.437 and 1.58, respectively. Limit of detection (LOD)and limit of quantification (LOQ) were observed to be 0.20ng/mL and 0.68 ng/mL, respectively.