Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DICLOFENAC SODIUM AND PARACETAMOL IN TABLET DOSAGE FORM

*Arunima Aravind V. P., Prothibha das and Dr. Ajith Babu T. K.

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Abstract

A simple, rapid, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Diclofenac sodium and paracetamol in tablet dosage form. Phenomenex C18 column (250 mm X 4.6 mm i.d., 5 μm particle size) in Isocratic mode with mobile phases containing phosphate buffer (pH 5.5) and Acetonitrile (70:30 %v/v) was used. The flow rate was 1.0mL/min and effluents were monitored at 280 nm.) The retention time of Diclofenac sodium and paracetamol was 2.90min and 5.27min respectively. The concentration curves of Diclofenac sodium and paracetamol were linear in the concentration range of 2-10 μg/mL and 10-50 μg/mL respectively. The developed method was validated for specificity, precision, linearity, accuracy, LOD, LOQ, robustness. The developed method can be successfully applied in routine quality control analysis.

Keywords: Paracetamol, Diclofenac sodium RP-HPLC method, simultaneous estimation.