Recent Development and Validation of Tolperisone HCl and Diclofenac Sodium in Bulk and Pharmaceutical Dosage Forms by Using RP HPLC Method

Abstract

High-performance liquid chromatography is at present one of the most sophisticated tools for analysis. The estimation of Tolperisone HCl and Diclofenac sodium was done by RP-HPLC. Tolperisone is an oral, centrally-acting muscle relaxant.  The Phosphate buffer was p^H 3.0 and the mobile phase was optimized consisting of Methanol: Phosphate buffer mixed in the ratio of 70:30% v/ v. Inertsil C18 column C18 (4.6 x 150mm, 5\(\mu\)m) or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using a UV detector at 260 nm. The samples are weighed using the Afcoset ER-200A weighing balance. The solutions were chromatographed at a constant flow rate of 0.8 ml/min. the linearity range of Tolperisone HCl and Diclofenac sodium was found to be from 100-500 \(\mu\)g/ml of Tolperisone hcl and 1-5\(\mu\)g/ml of Diclofenac sodium. The linear regression coefficient was not more than 0. 999. The values of % RSD are less than 2% indicating the accuracy and precision of the method. The percentage recovery varies from 98-102% of Tolperisone HCl Diclofenac sodium. LOD and LOQ were found to be within the limit. The results obtained on the validation parameters met ICH and USP requirements.