📄 Abstract
Ledipasvir is a potent direct-acting antiviral agent widely employed in combination therapy for chronic hepatitis C virus infection. Accurate analytical methods are essential for routine quality control, stability evaluation, and regulatory compliance. Although several chromatographic methods have been reported, there remains a need for a rapid, economical, and stability-indicating RP-HPLC method suitable for routine pharmaceutical analysis. The thesis underlying this manuscript describes analytical method development and validation in this context. The present investigation aimed to develop and validate a stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method for the quantitative estimation of Ledipasvir in bulk drug and pharmaceutical dosage forms following International Council for Harmonisation (ICH) guidelines. Chromatographic separation was achieved using a C18 reversed-phase analytical column under optimized chromatographic conditions. Method validation included specificity, linearity, accuracy, precision, robustness, ruggedness, limit of detection (LOD), limit of quantification (LOQ), and forced degradation under acidic, alkaline, oxidative, thermal, and photolytic conditions. The experimental workflow follows the thesis methodology for method development, validation, and degradation studies. The validated RP-HPLC method represents a simple, economical, precise, and reliable analytical procedure suitable for routine quality control analysis and stability testing of Ledipasvir pharmaceutical formulations.
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📚 How to Cite:
Mohit Patel, Dr. Arun Patel, Mr. Shailendra Patel , STABILITY INDICATED SPECTROPHOTOMETRIC AND RP-HPLC METHOD FOR THE ESTIMATION OF LEDIPASVIR BULK AND FORMULATION , Volume 11 , Issue 7, July 2026, EPRA International Journal of Research & Development (IJRD) , Pages: 363 - 371 ,