Stability-Indicating Chromatographic Methods

Bys: Pethani, Trupesh, Thumar, Mayuri, Bavaliya, Paresh

The present work focused on developing and validating simple, precise, accurate, sensitive, and stability-indicating chromatographic methods for the simultaneous estimation of Tolperisone Hydrochloride and Diclofenac Sodium in combined pharmaceutical dosage forms. Although RP-HPLC and HPTLC methods had been reported for their assay, no stability-indicating methods were available in literature. Hence, methods were developed as per ICH guidelines to ensure reliability in quality control. The optimized RP-HPLC method employed a Kromasil C18 column with methanol, acetonitrile, and water (80:16:4, pH 3.0) as mobile phase, showing retention times of 2.93 min for Tolperisone and 4.20 min for Diclofenac. The HPTLC method used silica gel 60 F254 plates with methanol: toluene: ethyl acetate (2.5:7:0.5 v/v/v), yielding Rf values of 0.5 and 0.7, respectively. Both methods were validated for linearity, precision, accuracy, robustness, LOD, and LOQ, with recoveries close to 99-100%. Forced degradation under acidic, alkaline, oxidative, thermal, and photolytic conditions confirmed method specificity, revealing Tolperisone to be more labile than Diclofenac.

• Format: Paperback
• Language: English
• ISBN: 6208462347
• ISBN13: 9786208462345
• Release Date: September 2025
• Publisher: LAP Lambert Academic Publishing
• Length: 112 Pages
• Weight: 0.35 lbs.
• Dimensions: 0.3" x 6.0" x 9.0"