RP-HPLC method for simultaneous estimation of Drotaverine hydrochloride and Aceclofenac in their combined tablet dosage form

Drotaverine hydrochloride and aceclofenac are prescribed for the treatment of adult patients with muscular pain associated with spasm. This study describes a rapid, simple, precise and accurate RP-HPLC method for simultaneous estimation of drotaverine hydrochloride and aceclofenac in their combined tablet dosage form. The separation was achieved on a Phenomenex-Gemini (150mm x 4.6mm, 5 μm) column with an isocratic mixture of methanol, acetonitrile and water in the ratio of 60:30:10, pH adjusted to 3.0, at a flow rate of 1.0 ml/min and UV detection at 298.5 nm. The retention time for drotaverine hydrochloride and aceclofenac was 1.06 and 4.19 min respectively. The method was linear in the range of 8-40 μg/ml and 10- 50 μg/ml for drotaverine hydrochloride and aceclofenac respectively. The correlation coefficients were 0.9997 for drotaverine hydrochloride and 0.9995 for aceclofenac. The method was validated as per ICH guidelines and successfully applied for estimation of drotaverine hydrochloride and aceclofenac in commercially available tablet dosage form.