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. - Tapa blanda

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.
Tapa blanda
ISBN 10: 6202433051 ISBN 13: 9786202433051
Editorial: LAP Lambert Academic Publishing, 2025

Sinopsis

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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Editorial
LAP Lambert Academic Publishing
Año de publicación
2025
Idioma
Inglés
ISBN 10 
6202433051
ISBN 13 
9786202433051
Encuadernación
Tapa blanda
Número de páginas
104
Contacto del fabricante
no disponible
Persona responsable
no disponible