DEVELOPMENT AND VALIDATION BY RP-HPLC FOR THE IN-VITRO RELEASE OF LERCANIDIPINE HYDROCHLORIDE IN TABLET DOSAGES FORM.

A simple, accurate, precise and reproducible method was developed and validated by Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for estimation of Lercanidipine Hydrochloride in tablet dosage form. An isocratic RP-HPLC method was developed on C-18 Column, Cosmosil, (150 mm x 4.6mm) 5µm using Methanol, buffer (Mix 1.0 ml of orthophosphoric acid in 1000 ml of water) and Tetrahydrofuran in the ratio of 890:100:10 as mobile phase. The flow rate was adjusted to 1.0 ml/min and the detection wavelength was 220 nm. The retention time for Lercanidipine Hydrochloride was found to be 6.52. Detection response for Lercanidipine Hydrochloride was found to be linear low in concentration range of 78-182 mcg/ml in the linearity study, regression equation and coefficient of correlation for Lercanidipine Hydrochloride was found to be (y = 4002.5x + 459.10, r2 =0.99996). Proposed method was validated for specificity, accuracy, precision, linearity, range, ruggedness & robustness. This developed method can be applicable for routine quantitative analysis. Keywords: Lercanidipine Hydrochloride, RP- HPLC, Validation, IVR (In-Vito Release