RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF PARACETAMOL, DICLOFENAC SODIUM AND DICYCLOMINE IN PHARMACEUTICAL FORMULATION

Abstract

A simple, accurate, precise and selective RP-HPLC method was developed and validated for the simultaneous determination of Paracetamol, diclofenac sodium and dicyclomine HCl. Chromatographic separation of Paracetamol, diclofenac sodium and dicyclomine HCl was achieved on C18 column buffer: acetonitrile as the mobile phase in the ratio of 30:70 V/V with pH 4 with detection at a wavelength 215nm with flow rate of 1.0 mL/min. The total eluting time for the three components is less than eight minutes and the retention time was 2.6 min, 3.5 min and 6.0 min for Paracetamol, diclofenac sodium and dicyclomine HCl, respectively. They were determined with the concentration ranges of 5-15μg/mL for Paracetamol, 2-10 µg/mL for diclofenac sodium and 50-150 μg/mL for dicyclomine HCl, respectively. The correlation coefficient was found to be 0.996, 0.999 and 0.996 for Paracetamol, diclofenac sodium and dicyclomine HCl at selected wavelength. The method was validated as per standard analytical procedures, and the results were found to be within limit. Percentage recoveries obtained for the three drugs were 98.1-99.3%, 97.9-100.6% and 99.5-101% Paracetamol, diclofenac sodium and dicyclomine HCl, respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of Paracetamol, diclofenac sodium and dicyclomine HCl from their tablet dosage form.