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Abstract
Method validation for Separation Pregabalin impurity –B from Active pharmaceutical raw material by HPLC method by considering the validation parameter by HPLC. Verification of the method used for the analysis of Pregabalin USP active pharmaceutical raw material enantiometric purity for impurity–B by HPLC.This method was is development for alternate vendor source of the material to use multiple vendor during formulation. The monograph on pregabalin from the United States Pharmacopeia (USP) states different high performance liquid chromatography (HPLC) methods for the assay, the determination of organic impurities, and the determination of enantiomeric purity. In the United States Pharmacopeia (USP), the monograph on pregabalin states different high performance liquid chromatography (HPLC) methods for the assay and the determination of enantiomeric purity. This application note describes the performance of the assay as well as the determination of enantiomeric purity according to USP on the Agilent 1260 Infinity II Prime LC with a column selection valve. Both methods can be performed on one LC system with no manual intervention required. Furthermore, the assay and determination of enantiomeric purity for pregabalin are transferred to UHPLC conditions in accordance with USP guidelines, chapter 621, enabling time and solvent savings.