Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DROTAVERINE HYDROCHLORIDE AND ACECLOFENAC IN BULK AND FORMULATION BY RP-HPLC

Dr. Ch. Saibabu*, D. Chinni Krishna Reddy, Dr. M. Bhaskar

Abstract

A reserve phase liquid chromatography (RP-HPLC) method has been developed and subsequently validated for the determination of Drotaverine hydrochloride and Aceclofenac in bulk and its pharmaceutical formulation. Separation was achieved with an Inertsil Cyano (CN) column, 250mm x 4.6mm (particles with 5µm). A mixture of methanol and 0.1% formic acid and 0.1ml of 0.1% TEA (70:30) as mobile phase at a flow rate of 1 ml/min and the column temperature was maintained at 25˚c. Dual wavelength detector was performed at 231 nm and sample temperature was maintained at 5˚c with a run time of 10 minutes. The method was rapid, simple and sensitive. The described method of drotaverine hydrochloride and aceclofenac is linear in the range of 10-50µg/ml with correlation coefficient of 0.999 respectively for both Drotaverine hydrochloride and Aceclofenac. The method enables accurate, precise and rapid analysis of Drotaverine hydrochloride and Aceclofenac. It can be conveniently adopted for routine quality control analysis of bulk and pharmaceutical formulation.

Keywords: HPLC, Drotaverine ydrochloride.