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Method Validation and Stability Analysis of Rifampicin by LC and LC-MS

By Trupesh Pethani

Method Validation and Stability Analysis of Rifampicin by LC and LC-MS

By Trupesh Pethani

0 - Default Title
Description
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.
Product details
Binding:
Paperback
Number of Pages:
104
Release Date:
2025-09-18
Publication Date:
2025-09-18
Publisher:
LAP LAMBERT Academic Publishing
Languages:
Original: English
ISBN10:
6202433051
ISBN13:
9786202433051
GPSR Manufacturer Reference:
[email protected]
Weight:
173 g
Height:
150 cm
Width:
220 cm
Thickness:
7 cm
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