Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SORAFENIB BY RP-HPLC

Km Sumit Kumari* and Hridesh Singh

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Abstract

This review brings together current advancements in RP‑HPLC method development and validation for Sorafenib, covering both bulk drug and tablet dosage forms, and is further supported by short confirmatory experiments to highlight practical aspects. Most reported chromatographic methods rely on C18 columns operated under high organic mobile phases-commonly acidified acetonitrile-water or acetonitrile-methanol systems-combined with UV/PDA detection around 263-266 nm. These setups provide efficient separations with short analysis times, sharp and symmetrical peaks, and the throughput required for routine quality control. The development process typically focuses on fine‑tuning the mobile‑phase strength and pH, selecting detection wavelengths close to Sorafenib’s absorption maxima, and ensuring that system suitability parameters are met for peak resolution and integrity. Validation data consistently align with ICH Q2 (R1) guidelines, demonstrating strong linearity (average r² ≈ 0.999), high precision with repeatability and intermediate precision (%RSD

Keywords: RP-HPLC (Reversed-Phase High-Performance Liquid Chromatography), Sorafenib, method development, validation and literature trends.