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

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.