Stability Indicating RP-HPLC Method for Determination of Drotaverine HCL and Mefenamic Acid in Pure and Pharmaceutical Formulation

Objective: A Stability indicating Reverse-Phase liquid chromatographic method for the simultaneous estimation of Drotaverine HCl and Mefenamic acid was developed. Method: The chromatographic assay involves the use of Hi Q C-18 W (5μm column with a simple mobile phase containing 80:20% v/v of methanol & HPLC Grade water (0.1% triethylamine at pH 3) with flow rate of 1.0mL/min with UV detection at wavelength of 250 nm. Result: The method showed good linearity in the concentration range of 2-10 μg/mL for Drotaverine Hcl and 6-30 μg/mL for Mefenamic Acid. Conclusion: The developed method was successfully validated as per the ICH guidelines. The stability indicating capacity was also tested and successfully applied to marketed formulation