Analytical Method Development and Validation for Larcenidepin and its Stages by High Performance Liquid Chromatography

Objective: To develop and validate a rapid, precise, robust, cost-effective HPLC method for separating Lercanidipine and its impurities as per the latest regulatory requirement and regulatory expectations. Methods: The Lercanidipine and Impurities resolved on Inertsil ODS 3V 150 X 4.6 mm, C18 column using a mobile phase system containing 0.1% TFA: Acetonitrile (50:50 v/v.) at detector wavelength 225 nm, with flow rate 1.0 ml/min and column temperature 300C. Results: Good linearity was observed for Lercanidipine impurity over the concentration range of 50 - 250 and micro;g/ml, with the linear regression (Correlation coefficient R = 0.999) and proved to be robust. The LOD and LOQ of Lercanidipine were 50 ng/ml and 500ng/ml, respectively, for a 10 and micro;L injection volume. Lercanidipine sample solution and mobile phase were stable for at least 48 hours. The % RSD for the assay content in six sample solutions is 0.04. Hence the method for the determination of Lercanidipine assay is precise. Conclusion: The developed HPLC method was simple, reliable, and cost-effective for Lercanidipine using the reverse mobile phase and validated as per ICH guidelines. The developed method can be used to quantitatively determine Lercanidipine in bulk drug materials in the pharmaceutical industry.