Abstract

DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DICLOFENAC AND MISOPROSTOL IN COMBINED DOSAGE FORM

Komal Nishikant Khillare*, Prof. Sachin S. Rane, Dr. Rajesh Y. Chaudhari and Dr. Vijay R. Patil

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Abstract

HPLC method has been used for simultaneous determination of Diclofenac Sodium and Misoprostol in formulation. This method is based on HPLC separation of the two drugs on the Thermo Hypersil BDS–C18 (250 mm × 4.6 mm, 2.5 μ) from Agilent with isocratic conditions and simple mobile phase containing methanol: 0.05%OPA water pH 2.7 (70: 30) at flow rate of 0.7 mL/min using UV detection at 235 nm. This method has been applied to formulation without interference of excipients of formulation. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 50-100 μg/mL for Diclofenac Sodium and 200-400 μg/mL for Misoprostol respectively. The method was validated for precision, robustness and recovery. The limit of detection (LOD) and limit of quantitation (LOQ) was 0.26μg/mL and 0.78μg/mL for Diclofenac Sodium and 1.87μg/mL and 5.6μg/mL Misoprostol respectively. Statistical analysis showed that the method is repeatable and selective for the estimation of Diclofenac Sodium and Misoprostol.

Keywords: HPLC, Diclofenac sodium, Misoprostol, Analysis of formulated drug.