STABILITY-INDICATING CHROMATOGRAPHIC METHODS: FOR TOLPERISONE AND DICLOFENAC - Softcover

Pethani, Trupesh; Thumar, Mayuri; Bavaliya, Paresh

Softcover

ISBN 10: 6208462347 ISBN 13: 9786208462345

Verlag: LAP LAMBERT Academic Publishing, 2025

Inhaltsangabe

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.

Über diesen Titel

Über die Autorin bzw. den Autor

Dr. Trupesh Pethani, Associate Professor at Saurashtra University, holds M. Pharm and Ph.D. in Pharmacy. He has published widely in reputed journals and books. His research focuses on method development, impurity profiling, drug stability, herbal standardization and nanotechnology.

Details zur Ausgabe

• Verlag: LAP LAMBERT Academic Publishing
• Erscheinungsdatum: 2025
• Sprache: Englisch
• ISBN 10: 6208462347
• ISBN 13: 9786208462345
• Einband: Taschenbuch
• Anzahl der Seiten: 112
• Kontakt zum Hersteller: preigu GmbH & Co. KG; mail@preigu.de; ; Lengericher Landstr. 19; Osnabrück; Niedersachsen; 49078; Deutschland