Satish A. Patel, Kaushik P Hariyani*
Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research,
Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.
A simple, sensitive, accurate, precise and rapid reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Tolperisone hydrochloride and Diclofenac sodium from synthetic mixture. The chromatographic separation was performed on ACE 5 C18 column (150 mm × 4.6 mm i.d, 5 μm particle size). Mobile phase consisted of a mixture of phosphate buffer pH 6, acetonitrile and methanol in the ratio of 10: 50: 40, v/v/v at a flow rate of 0.7 ml/min. The detection wavelength was set at 267 nm. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ. The calibration was linear over the concentration range of 2-30 μg/ml for Tolperisone hydrochloride and 2-30 μg/ml for Diclofenac sodium. The retention times were found to be 2.1 ± 0.14min for Diclofenac sodium and 4.7 ± 0.13min for Tolperisone hydrochloride. The mean recoveries were 100.5 ± 0.34 and 100.8 ± 0.80 for Tolperisone hydrochloride and Diclofenac sodium, respectively. The method can be easily adopted for quality control analysis.