DEVELOPMENT AND VALIDATION OF RP-HPLC FOR SIMULTANEOUS ESTIMATION OF PREGABALIN AND ETORICOXIB IN PHARMACEUTICAL TABLET DOSAGE FORMAbstract
A simple, precise, rapid, linear and economical RP-HPLC method was developed and validated for simultaneous estimation of Pregabalin and Etoricoxib in pharmaceutical tablet dosage form. The determination was performed on Phenomenex C18 (250 mm × 4.6 mm, ID, 5µ) column at 30 ºC temperature using a mobile phase Acetonitrile: Water (55:45 %v/v) at a flow rate of 0.8 ml/min was employed. The RP-HPLC detection wavelength was 200 nm and 235 nm for Pregabalin and Etoricoxib, respectively. This method obeys Beers law in employed concentration range 2.4-12 µg/ml and 0.8-4 µg/ml for Pregabalin and Etoricoxib, respectively. The correlation coefficient of Pregabalin and Etoricoxib was found to be 0.9993 and 0.9997, respectively. The retention time was 2.680 and 7.383 minutes. The percentage RSD for accuracy and precision was found to be less than 2%. The method was validated as per ICH guidelines for its selectivity, specificity, system suitability, linearity, range, precision, accuracy, LOD, LOQ, robustness, assay. The method was successfully employed for routine quality control analysis of Pregabalin and Etoricoxib in pharmaceutical formulation.
M. B. Karanjkar
Department of Quality Assurance Techniques, S.V.P.M. College of Pharmacy Malegaon (BK), Maharashtra, India.
08 May 2021
08 June 2021
09 June 2021
01 February 2022