Author(s): S.D.Shanmugakumar*1, Nallapavani2
A simple, accurate and cost effective bioanalytical isocratic reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of diclofenac sodium (DFS) and tolperisone hydrochloride (TOL) in tablet dosage forms.The method developed in Shimadzu HPLC system on C-18 column (4.6X250mm, 5μ,100A°) with a mobile phase composed of methanol:0.1% formic acid in water (90:10 V/V) and flow rate of 1.0mL/min and injection volume 20μL.Detection of common wavelength was carried out at isobestic point of both the drugs at 255nm. The retention time of diclofenac sodium and tolperisone hydrochloride were found to be 4.2min and 2.6 min respectively. Plasma spiking studies were also performed using rat plasma. This developed method was validated for LOD, LOQ,linearity,precision,reproducibility,specificity,systemsuitability, robustness and ruggedness as per the ICH guidelines.