Development and Validation of Analytical Methods for Drotaverine and Nimesulide Combination

Abstract

A new simple, specific, precise and accurate reversed-phase liquid chromatography method has been developed for simultaneous estimation of Drotaverine HCl (DRO) and Nimesulide (NIM) in tablet formulation. The separation was achieved on a 5-micron C18 column (250 X 4.6 mm) using mobile phase consisting of a mixture of Acetonitrile: water: triethylamine (70:30:0.2 v/v, pH 3, adjusted with orthophosphoric acid).The flow rate was maintained at 1.0 ml/min, with an average operating pressure of 2630 psi. The detection of the constituents was done using UV detector at 230 nm for DRO and NIM. The retention time of DRO and NIM were approximately 2.98 and 5.73 min respectively. Recovery study values of DRO and NIM is 99.44±0.095 and 99.62±0.085 respectively, relative standard deviation of less than 2% for the assay show that the method is precise, accurate and linear in the concentration given and demonstrate the method developed is rugged and robust. Linear response obtained for DRO was in the concentration range 10-80 μg/mL and NIM in range of 25-200 μg/ml.