Method Validation and Stability Analysis of Rifampicin by LC and LC-MS: Stability Studies of Rifampicin: Method Validation, and Characterization of Degradation Products by LC and LC-MS. - Softcover

Pethani, Trupesh; Thumar, Mayuri; Korat, Shruti

 
9786202433051: Method Validation and Stability Analysis of Rifampicin by LC and LC-MS: Stability Studies of Rifampicin: Method Validation, and Characterization of Degradation Products by LC and LC-MS.
Softcover
ISBN 10: 6202433051 ISBN 13: 9786202433051
Verlag: LAP LAMBERT Academic Publishing, 2025

Inhaltsangabe

This book presents a comprehensive study on the stability of rifampicin, a first-line anti-tuberculosis drug, through method development, validation, and characterization of its degradation products. It begins with an overview of tuberculosis, rifampicin's pharmacological profile, and the importance of stability-indicating methods in pharmaceutical quality control. Using HPLC and LC-MS techniques, the study optimizes chromatographic conditions and develops a validated stability-indicating method as per ICH guidelines. Forced degradation experiments under acidic, alkaline, oxidative, photolytic, and thermal stress reveal rifampicin's susceptibility to hydrolysis and other degradative pathways, with detailed characterization of degradation products. The validated method demonstrated accuracy, precision, linearity, robustness, and suitability for analyzing rifampicin in bulk and dosage forms. The work highlights the scientific and regulatory significance of stability testing in ensuring drug safety, efficacy, and quality throughout its shelf life, offering valuable insights for pharmaceutical research and development.

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Über die Autorin bzw. den Autor

Dr. Trupesh Pethani, Associate Professor at Saurashtra University, is a distinguished researcher in pharmaceutical sciences. Holding M. Pharm and Ph.D., he has contributed extensively to journals and books. His expertise includes method development, drug stability, impurity profiling, herbal standardization and nanotechnology.

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Verlag
LAP LAMBERT Academic Publishing
Erscheinungsdatum
2025
Sprache
Englisch
ISBN 10 
6202433051
ISBN 13 
9786202433051
Einband
Taschenbuch
Anzahl der Seiten
104
Kontakt zum Hersteller
preigu GmbH & Co. KG
mail@preigu.de

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