| Title: |
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CENTRAL MUSCLE RELAXANT & ANALGESIC DRUG IN PHARMACEUTICAL FORMULATION. |
| Authors: |
Sonawane, Ganesh; Pansare, Kajal; Patil, Chandrashekhar; Bhong, Prabha; Somavanshi, Deepak; Pathade, Parag |
| Source: |
Cuestiones de Fisioterapia; 2025, Vol. 54 Issue 1, p1-16, 16p |
| Subject Terms: |
Muscle relaxants; Ultraviolet spectrophotometry; High performance liquid chromatography; RF values (Chromatography); Quality control |
| Abstract: |
A robust and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Diclofenac Sodium (DIC) and Tolperisone Hydrochloride (TOL) in pharmaceutical formulations. The study also employed derivative UV spectrophotometry as a complementary analytical technique. The UV spectrophotometric method utilized first-order derivative spectra with zero crossing points at 248 nm for DIC and 226 nm for TOL, ensuring accurate quantification. The method demonstrated good linearity for DIC (2-10 µg/mL) and TOL (5-25 µg/mL), with correlation coefficients close to 1. Precision, accuracy, and sensitivity were confirmed through recovery studies, with mean recoveries of 99.087-100.35% and 99.93-100.46% for DIC and TOL, respectively. The RP-HPLC method was optimized using a BDS Hypersil C18 (250mm × 4.6mm × 5µm) column with a mobile phase of 20 mM phosphate buffer (pH 3.5): acetonitrile (50:50 v/v), a flow rate of 1.0 mL/min, and UV detection at 268 nm. The retention times were 3.50 min for DIC and 5.26 min for TOL. System suitability parameters, including peak symmetry, theoretical plates, and resolution, were within acceptable limits. The method was validated according to ICH guidelines and successfully applied for the quantitative estimation of DIC and TOL in tablet dosage forms, demonstrating its suitability for routine pharmaceutical quality control. [ABSTRACT FROM AUTHOR] |
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| Database: |
Complementary Index |