Validated RP-HPLC Method as a Tool for Simultaneous Estimation of Drotaverine HCL And Mefenamic Acid in Combined Tablet Dosage Form

Author(s): P. Raghavendra, P. M. Vasanth, T. Ramesh and M. Ramesh

A simple, linear, accurate and precise RP-HPLC method has been developed for the simultaneous estimation of Drotaverine HCl and Mefenamic acid in tablet dosage form. The method was developed on HPLC Waters 2695 using BDS Hypersil C8 Column (100 x 4.6 mm, 5 µ) and the mobile phase of potassium dihydrogen phosphate (pH-2): methanol. Isocratic elution with a flow rate of 1 mL/min was employed at 30o C and the responses were measured at 244 nm by using Waters PDA 2998 detector. The retention times of Drotaverine HCl and Mefenamic acid were found to be 2.033 and 6.659 min. The method shows linearity in the range of 25-75 µg/mL and correlation coefficient was found to be 0.999 for both the drugs. The method was validated as per ICH guidelines and met all specifications including force degradation studies. Statistical studies revealed that the proposed method can be successfully applied for routine analysis of Drotaverine HCl and Mefenamic acid in tablet dosage forms.

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