Abstract

A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PITOFENONE, DICLOFENAC POTASSIUM AND FENPIVERINIUM BROMIDE IN PHARMACEUTICAL TABLET DOSAGE FORM

K. S. Chakravarthi* and N. Devanna

ABSTRACT

A simple, rapid, accurate, precise, specific and sensitive reverse phase-HPLC method has been developed and validated for the simultaneous estimation of Pitofenone, Diclofenac Potassium and Fenpiverinium Bromide in bulk drug and pharmaceutical dosage form. The chromatographic separation was performed on the Kromasil C18 column (250mm×4.6mm, 5μm particle size), using a mobile phase of Buffer: Acetonitrile taken in the ratio 35:65 v/v, at a flow rate of 1.0 ml/min at an ambient temperature of 30˚C with the detection wave length at 215nm. The retention times of Pitofenone, Diclofenac Potassium and Fenpiverinium Bromide were 2.48 min, 3.85 min and 5.23 min respectively. The linearity was performed in the concentration range of 125-750 ppm, 12.5-87.5 ppm, 0.25-1.5 ppm each of Pitofenone, Diclofenac Potassium and Fenpiverinium Bromide with a correlation coefficient of 0.999, 0.999 and 0.999 for Pitofenone, Diclofenac Potassium and Fenpiverinium Bromide respectively. The percentage purity of Pitofenone, Diclofenac Potassium and Fenpiverinium Bromide was found to be 99.43%, 100.07% and 99.66% respectively. The proposed method has been validated for specificity, linearity, range, accuracy, precision and robustness were within the acceptance limit according to ICH Q2 (R1) guidelines and the developed method can be employed for routine quality control analysis in the bulk and combined pharmaceutical dosage form of Pitofenone, Diclofenac Potassium and Fenpiverinium Bromide.

Keywords: Pitofenone, Diclofenac Potassium, Fenpiverinium Bromide, RP-HPLC, Validation.