Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF PARACETAMOL, ACECLOFENAC AND RABEPRAZOLE SODIUM IN PHARMACEUTICAL DOSAGE FORMS BY UPLC

Pulagurtha Bhaskararao* and D. Gowri Sankar

ABSTRACT

The present study is carried out using the Ultra Performance Liquid Chromatography as the analytical technique in developing and validating an accurate, precise, linear and robust analytical method for the simultaneous estimation of Paracetamol, Aceclofenac, Rabeprazole Sodium in tablets. The method is optimized with a mixture of 0.1%orthophosphoric acid and Acetonitrile in the ratio of 35:65 (V/V) as mobile phase and Acquity HSS C18 (2.1 x100) mm 1.8m as stationary phase. The Chromatographic peaks were detected and measured at 215nm. The retention times of paracetamol. aceclofenac and Rabeprazole sodium were found to be 0.33,0.66 and 1.12. The developed method is demonstrated to access its suitability for meeting its intended purpose by the Validation with a set of validation parameters as per ICH and USP guidelines. The method is found to be precise with %RSD 0.4, 0.4 and 0.2 %, accurate with the recoveries of Paracetamol, Aceclofenac and Rabeprazole sodium 99.83 to101.24,99.12 to 99.61 and98.97 to 99.02%. The method is proved to be linear from the conc.125 to750ppm for Paracetamol 25 to 150, Aceclofenac and conc. 2.5 to 15ppm for Rabeprazole with the correlation coefficients of 0.9983, 0.9987 and 0.999 respectively.

Keywords: Paracetamol, Aceclofenac, Rabeprazole Sodium, UPLC, Validation.