Work

Identification and assessment of novel degradants in pazopanib hydrochloride using stability-indicating RP-HPLC method

Year: 2025

Type: article

Abstract: Pazopanib, a multi-targeted tyrosine kinase inhibitor, is used in cancer treatment. This study developed and validated an RP-HPLC method for assessing Pazopanib stability, identifying impurities and characterizing degradants from forced degradation studies of tablet forms. Using a YMC Triart C18 column (250 mm × 4.6 mm, 5 µm), gradient elution occurs over 50 minutes at 268 nm. The mobile phase consists of Mobile phase A (0.1% Perchloric acid buffer and tetrahydrofuran) and Mobile phase B (0.1% Perchloric acid buffer, tetrahydrofuran, methanol, and acetonitrile). Method reliability was validated following ICH Q2 (R1) guidelines, with LOD and LOQ at 0.15 µg mL−1 and 0.50 µg mL−1. Forced degradation studies showed Pazopanib degrades under oxidative conditions but remains stable under other conditions. Five novel degradants were identified. Our RP-HPLC method, provides higher resolution and precision for Pazopanib impurity profiling, considering excipient interactions in tablet dosage form, and complies with ICH Q2 (R2) guidelines.

Source: Journal of Taibah University for Science

DOI: 10.1080/16583655.2025.2487722

Authors: Rohit Prajapati, Mehul Patel, Pritesh Desai, Charmy Kothari

Institutions: Charotar University of Science and Technology, Zydus Lifesciences Limited (India), Nirma University

Language: English

Topic: Analytical Methods in Pharmaceuticals

Subfield: Analytical Chemistry

Field: Chemistry

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $944