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

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.