Published January 8, 2025 | Version v1

Stability-Indicating RP-HPLC Method Development and Validation of Lonafarnib in Pure and Pharmaceutical Dosage Forms

Description

Developing robust, stability-indicating analytical methods is a cornerstone of pharmaceutical quality control, ensuring the safety and efficacy of medications. This review focuses on the development and validation of reverse-phase high-performance liquid chromatography (RP-HPLC) methods for analyzing Lonafarnib, a farnesyltransferase inhibitor used in the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS) and other disorders. Emphasis is placed on method development strategies, critical validation parameters, and the challenges encountered in analyzing both the pure drug and its formulated products. Detailed guidelines for forced degradation studies, method optimization, and regulatory compliance are provided. This paper serves as a comprehensive resource for researchers and industry professionals aiming to ensure Lonafarnib's quality and stability.

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