VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS DETERMINA TION OF DROTAVERINE AND NIMESULIDE AND ITS APPLICATION IN DRUG FORMULATION

A rapid, sensitive and specific RP-HPLC method involving UV detection was developed and validated for determination and quantification of Drotaverine and Nimesulide . Chromatography was carried out on a Phenomenex ‐ Luna, C8 (250 x 4.6 mm i.d.,5 µ) column. using filtered and degassed mixture of methanol:wat er(70:30)as mobile phase at a flow rate of 1.0 ml/min and effluent was monitored at 229.5nm. The method was validated in terms of linearity, precision, accuracy and specificity. The assay was linear over the concentration range of 10.0-30.0 mcg/ml and 12.5-75.0 mcg/ml for Drotaverine and Nimesulide respectively. Accuracy of the method was determined through recovery studies by adding known quantities of standard drug to the pre analyzed test solution and was found to be 98.54-99.87% and 98.22%98.29% for Drotaverine and Nimesulide respectively. The method requires less than 10 minutes as run time for analysis which prove the adoptabili ty of the method for the routine quality control of the drug.