Validated Stability Indicating RP-HPLC method for the Simultaneous Estimation of Drotaverin HCl & Aceclofenac in Bulk and Formulation

The present research work deals with the development and validation of stability indicating RP-HPLC method for the simultaneous estimation of Aceclofenac and Drotaverin HCl in bulk and formulation. Chromatographic separation was achieved on ODS HG-5 RP   C18(250 X 4.6 mm, 5 µm) using the mobile phase consisting of Acetonitrile and1% triethylamine (TEA) in the ratio of 90:10 pH  2.16 adjusted with Ortho phosphoric acid. The mobile phase was pumped at a flow rate of 1.0 mL/min and UV detection was observed at 224 nm. The retention time was found to be 3.57 min for Aceclofenac and 6.15 min for Drotaverin HCl. The linearity concentrations are obtained from in the range of 30-70 µg/ml for Aceclofenac and 24-56 µg/ml for Drotaverin HCl respectively with correlation coefficient was 0.999 and 0.998. The proposed method was found to be simple, accurate, precise and reproducible and developed method can be suggest to routine quality control analysis for simultaneous estimation of Aceclofenac and Drotaverin HCl in pharmaceutical dosage forms.