Monday, 18 March 2024

Recent Development and Validation of Tolperisone HCl and Diclofenac Sodium in Bulk and Pharmaceutical Dosage Forms by Using RP HPLC Method | Chapter 5 | Advanced Concepts in Pharmaceutical Research Vol. 7

 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 pH 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, 5µm) 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 µg/ml of Tolperisone hcl and 1-5µg/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.


Author(s) Details:

M. Archana,
School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies, PV Vaithiyalingam Rd., Velan Nagar, Krishnapuram, Pallavaram, Chennai, Tamil Nadu – 600043, India.

M. Sumithra,
School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies, PV Vaithiyalingam Rd., Velan Nagar, Krishnapuram, Pallavaram, Chennai, Tamil Nadu – 600043, India.

Please see the link here: https://stm.bookpi.org/ACPR-V7/article/view/13543

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