Development and Validation of RP-HPLC Method for Estimation of Lacosamide in Bulk and Its Pharmaceutical Formulation

Abstract

Objective - The present paper describes a simple, accurate, and precise reversed-phase high-performance liquid chromatography (HPLC) method for rapid and simultaneous quantification of Lacosamide in bulk and pharmaceutical dosage form. Methods: The chromatographic separation was achieved on C18 (250mmx4.6mm, 5µ id). Mobile phase contained a mixture of methanol: phosphate buffer in the ratio of 35:65(PH 3) v/v, flow rate 1.0 ml/min and ultraviolet detection at 210 nm. Results: The retention time Locosamide was 0.21 min. The proposed method shows a good linearity in the concentration range of 02 to 12μg/ml for locosamide under optimized conditions. Precision and recovery study results are in between 95.37 to 97.95 % w/w.. In the entire robustness conditions, percentage relative standard deviation is. Conclusion: This method is validated for different analytical performance parameters like linearity. Precision, accuracy, limit of detection, limit of quantification, robustness, and pharmacokinetic study were determined according to the International Conference of Harmonization (ICH) Q2B guidelines. All the parameters of validation were found in the acceptance range of ICH guidelines.