SIMPLE AND SENSITIVE METHOD FOR THE SIMULTANEOUS ESTIMATION OF DROTAVERINE HCL AND ACECLOFENAC USING RP-HPLC

To develop a simple and sensitive method for the simultaneous estimation of drotaverine HCL (DRH) and aceclofenac (AF) using RP-HPLC. The HPLC separation was achieved on a thermo column (250 mm × 4.6 mm, 5μ) with an isocratic mixture of acetonitrile and 5 mM of ammonium acetate in the ratio of 65:35, pH adjusted to 4.5 at a flow rate of 1.0 ml/min and the detection at 285nm. The method was validated as per ICH guidelines. The retention time for DRH and AF was 3.9 and 5.0 minutes, respectively. The optimized method was linear in the range of 50 - 120 ng/ml and 100 - 700 ng/ml for DRH and AF respectively. The overall recovery of DRH and AF were 99.8 and 99.5 % respectively. The developed sensitive, robust and rugged method as proven reproducibility of the result obtained as an outcome of small deliberate variation in the analytical parameter and the change the operator.