Method Development and Validation for the Simultaneous Estimation of Pitofenone Hydrochloride, Diclofenac Potassium and Fenpiverinium Bromide In Pharmaceutical Dosage Forms by UPLC

The present study is carried out using the UPLC as the analytical technique in developing and validating an accurate, precise, linear and robust analytical method for the simultaneous estimation of Pitofenone hydrochloride, Diclofenac potassium and Fenpiverinium bromide in tablets. The method is optimized with a mixture of 0.01M phosphate buffer (PH4.8) and Acetonitrile in the ratio of 40:60 (V/V) as mobile phase and Agilent SB C18 (250 X 4.6) mm, 5µm as stationary phase. The Chromatographic peaks were detected and measured at 215nm. The retention times of Pitofenone hydrochloride, Diclofenac potassium and Fenpiverinium bromide were found to be 1.0, 1.66 and 2.0 respectively. The developed method was 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 - 0.48, 0.69, 0.66 for Pitofenone hydrochloride, Diclofenac potassium and Fenpiverinium bromide respectively: accurate with the recoveries of 99.6 to 101.6, 100.51 to 101 and about 100% for Pitofenone hydrochloride, Diclofenac potassium and Fenpiverinium bromide respectively. The method is proved to be linear from the conc.12.5 to 75ppm for Pitofenone, 250 to750 ppm for Diclofenac and 0.5 to 1.5ppm for Fenpiverinium bromide with the correlation coefficients of 0.999, 0.999 and 0.999 respectively. Hence the developed method could be used for the routine analysis purpose in the evaluation of Pitofenone, Diclofenac potassium and Fenpiverinium bromide Tablets.