Quantitation of Pregabalin by HPLC-UV Method using Ninhydrin Derivatization: Development and Validation

Introduction: A simple and reliable high performance liquid chromatographic method has been developed for the quantitative determination of pregabalin in bulk dosage form. Pregabalin, a γ amino butyric acid analogue, negligible sensitivity to UV or fluorescence detection. Hence, it derivatized by ninhydrin form chromophoric complex that could be quantified Materials Methods: The concentration was set 5 mg/ml phosphate buffer solution (pH 7.4) used as solvent reaction. resultant separated HPLC detected detector at 569nm wavelength. Results: showed linear response within 50 600 μg/mL pregabalin. accurate with mean recovery values 100 ± 2%. repeatability established intra-day inter-day precision study. Finally, commercial capsule assayed including derivatization. result assay found 100.37 ±2.94 %. Conclusion: This is first time we are reporting analysis using derivatization analysis. Therefore, can considered significant improvement quantitation easily applied routine quality control tests