“Review on Development and Validation of RP-HPLC Method, And Techniques for Vorasidenib in Bulk Drug and Pharmaceutical Dosage Forms”

Abstract

Vorasidenib, a novel dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2), has gained considerable attention for its therapeutic potential in the treatment of low-grade gliomas and other IDH-mutant malignancies. Accurate and reliable analytical methods are essential for the quantitative estimation of Vorasidenib in bulk drug and pharmaceutical dosage forms to ensure quality, safety, and efficacy. Among the available analytical techniques, Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) has emerged as the method of choice due to its sensitivity, selectivity, reproducibility, and cost-effectiveness. This review highlights the development and validation strategies of RP-HPLC methods for Vorasidenib, focusing on critical parameters such as selection of stationary and mobile phases, optimization of chromatographic conditions, and detection wavelength. Method validation is discussed in accordance with ICH guidelines, covering accuracy, precision, linearity, specificity, robustness, limit of detection (LOD), and limit of quantitation (LOQ). Furthermore, the review emphasizes the application of validated methods in routine quality control and stability studies of pharmaceutical formulations. Overall, the article provides comprehensive insights into RP-HPLC method development for Vorasidenib, serving as a valuable reference for researchers and pharmaceutical analysts engaged in drug analysis and regulatory submissions.