Development of a Chromatographic Technique for Quantification of Drotaverine Hydrochloride and Diclofenac Potassium

Abstract

A straightforward RP-HPLC approach has been developed and validated for the simultaneous estimation of drotaverine hydrochloride (DROTA) and diclofenac potassium (DICLO) in their combined dosage form. This method was found to be simple, accurate, and precise. Chromatographic detection has been carried out on a Phenomenex C18 column (250 mm × 4.6 mm, i.d, 5 µm) with a flow rate of 1.0 ml/min using an isocratic mobile phase consisting of Methanol and Water (80:20 v/v, pH 3 adjusted with ortho phosphoric acid). The wavelength of 280 nm was chosen for the UV detection. The separation of DROTA and DICLO took less than ten minutes, had a good resolution, and produced very little tailing. There was no interference from any excipients. The method was validated in accordance with the ICH recommendations, and the criteria for accuracy, precision, linearity, and system adaptability were all satisfactory in each and every one of the cases.