Development and Validation of Novel RP-HPLC Method for Simultaneous Estimation of Tolperisone HCl and Diclofenac Sodium in Pharmaceutical Dosage Form

Development and Validation of Novel RP-HPLC Method for Simultaneous Estimation of Tolperisone HCl and Diclofenac Sodium in Pharmaceutical Dosage Form


Jani A, Vaghasiya S, Bagada H, Patel P


Abstract

A simple Reverse phase liquid chromatography method has been developed and subsequently validated for the tablet dosage form. Here solvent used was Methanol and mobile phase consisting Acetonitrile: Water: Triethylamine (95:5:0.01) pH set to 3.2 with O-Phosphoric acid gave resolution of peaks. C-18(250mm x 4.6mm i.d with particle size of 5 um) used with flow rate 1.2 ml/min using UV detection at 270 nm. The retention time of Diclofenac sodium and Tolperisone HCl were found at 3.1min and 2.4min respectively. In Which Linearity for DIC and TOL was found to be y = 36565x + 66101, R2 = 0.999 and y = 23278x + 1040 R2 = 0.998 in concentration range of 10-90 µg/ml for 30-270 µg/ml respectively. Recovery was found to be 99.16-100.5% for DIC and 98.62-100.32% for TOL. Other all the data (Precision, LOD and LOQ, Assay, Robustness) were within the specified criteria of ICH guideline.


Keywords

HPLC, Diclofenac sodium, Tolperisone HCl


Cite This Article

Jani, A., Vaghasiya, S., Bagada, H., & Patel, P. (2014). Development and Validation of Novel RP-HPLC Method for Simultaneous Estimation of Tolperisone HCl and Diclofenac Sodium in Pharmaceutical Dosage Form. International Journal for Pharmaceutical Research Scholars, 3(1), 847-853.

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