VALIDATED HPLC METHOD FOR SIMULTANEOUS QUANTITATION OF PARACETAMOL, DICLOFENAC POTASSIUM AND FAMOTIDINE IN BULK DRUG AND FORMULATION

Abstract

A simple, sensitive, precise and accurate HPLC method of analysis for paracetamol, diclofenac potassium, and famotidine both as a bulk drug and in tablet formulation was developed and validated. This method is based on HPLC separation of the three drugs on the PerfectSil-100 ODS-3–C18 (250 mm × 4.6 mm, 5.0 ?) column from Germany with isocratic mobile phase containing acetonitrile: water (30: 70, v/v) pH 9.0 adjusted with triethylamine at flow rate 1 mL/min. UV detection was performed at 274 nm with Rt of 3.80, 5.40 and 6.33 min for Paracetamol, Famotidine and Diclofenac Potassium respectively. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 81.25-406.25 ?g/mL for Paracetamol, 5-25 ?g/mL for Famotidine and 12.5-62.5 ?g/mL for Diclofenac Potassium. The method was validated for linearity, precision, robustness and recovery according to International Conference on Harmonization guidelines. Chromatographic interference from the tablet excipients was not found. Statistical analysis showed that the method was repeatable and selective for the simultaneous quantitation of the three drugs in tablet formulation and for routine quality control of raw materials of the drugs.