ABSTRACT

This work has been done with a motto to develop a simple, accurate, precise, reproducible and economic reverse phase HPLC method for Lacosamide in bulk drug as well as in formulations. In the current developed method C8H column (150×4.6mm) was used as stationary phase and Sodium dihydrogen phosphate monohydrate buffer (pH 2.5) & Acetonitrile in a gradient mode as mobile phase. ICH guidelines were followed for method validation and different parameters studied include linearity range, system suitability, specificity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), Robustness and Solution Stability. The developed validated method was also utilized to quantify the Lacosamide in the marketed formulation successfully. The method was found linear within the range of 40-140µg/mL whereas recovery was found within the range of 99.50% -100.70%. Method was found to be able to distinguish the parent drug from degraded products & quantify Lacosamide in Dosage form (103.80%). A linear, robust & economic RP-HPLC method was developed within the good range which can be adopted for the routine analysis of Lacosamide in bulk drugs & formulations. Keywords: Lacosamide, Assay, HPLC, Validation, Accuracy
Publication date: 15/12/2021

https://ijbpas.com/pdf/2021/December/MS_IJBPAS_2021_DEC_SPCL_1050.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.12.1050