RP-HPLC METHOD DEVELOPMENT AND VALIDATION APPROACHES FOR QUANTITATIVE ESTIMATION OF VENETOCLAX: A COMPREHENSIVE REVIEW

Ms. Aditi Arun Mhatre*, Mr. Akash Darekar, Prof. M. T. Mohite, Dr. Hemant V. Kamble

ABSTRACT

Venetoclax is a selective B-cell lymphoma-2 (BCL-2) inhibitor widely used in the treatment of hematological malignancies such as chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). Due to its growing therapeutic importance, the development of accurate, precise, and reliable analytical methods for its quantitative estimation has become essential in pharmaceutical research and quality control. Reverse Phase High Performance Liquid Chromatography (RP-HPLC) is one of the most preferred analytical techniques because of its high sensitivity, specificity, reproducibility, and cost-effectiveness in drug analysis. The present review focuses on various RP-HPLC method development strategies reported for Venetoclax, including selection of mobile phase, stationary phase, detection wavelength, and chromatographic conditions. The review also highlights validation parameters such as specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification according to ICH guidelines. In addition, stability-indicating methods and recent advancements in analytical approaches for Venetoclax estimation are discussed. This review aims to provide a comprehensive overview of RP-HPLC analytical methods for Venetoclax and emphasizes future perspectives toward the development of rapid, sensitive, eco-friendly, and regulatory-compliant analytical techniques in pharmaceutical analysis.

Keywords: Venetoclax, RP-HPLC, Method Development, Method Validation, Quantitative Estimation, Pharmaceutical Analysis, Stability-Indicating Method, ICH Guidelines, Analytical Method Validation, Chromatographic Techniques.