Development and Validation of Simultaneous RP-HPLC Method for Estimation of DROTAVERINE HCl and MEFENAMIC Acid in bulk and Pharmaceutical Formulations

A simple, specific, accurate and precise RP HPLC method has been developed for the simultaneous determination of Drotaverine HCl and Mefenamic Acid from combined dosage form by reverse phase C18 column (Younglin ( S.K) Gradient System UV (250mm x 4.6mm) 5μ). The sample was analysed using Methanol : Water in the ratio of 80:20( 0.1% triethylamine at pH 3 ) as a mobile phase at a flow rate of 1.0ml/min and detection at 250nm. The retention time for Drotaverine HCl and Mefenamic Acid was found to be 5.500 min and 9.550 min respectively. The stability assay was performed for this combination and was validated for accuracy, precision, linearity, specificity and sensitivity in accordance with ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the2-10 μg/mL for Drotaverine Hcl and 6-30 μg/mL for Mefenamic Acid, respectively, and recoveries from combined dosage form were between 98 and 102%. The method can be