Novel Stability-Indicating Assay for Palbociclib: A Breakthrough in Anti-Breast Cancer Therapy

Palbociclib, a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor, plays a crucial role in the treatment of hormone receptor-positive, HER2-negative metastatic breast cancer. Ensuring the accurate quantification and stability of Palbociclib in pharmaceutical formulations is critical for maintaining therapeutic efficacy and patient safety. Existing analytical methods often lack the precision, robustness, and cost-effectiveness required for routine quality control. In this study, a novel reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the reliable estimation of Palbociclib in solid dosage forms. The chromatographic separation was achieved using an ODS-3 C18 column with a mobile phase composed of trifluoroacetic acid buffer, acetonitrile, and methanol under gradient elution. The method demonstrated excellent linearity, precision, accuracy, specificity, forced degradation and stability-indicating capability in accordance with ICH and FDA guidelines. Key validation parameters, including system suitability, limit of detection, limit of quantification, robustness, and recovery, confirmed the reliability of the method. The developed RP-HPLC technique successfully separates Palbociclib from its known organic impurities with a high peak purity index, ensuring the method’s suitability for stability studies and routine pharmaceutical analysis. This approach offers a cost-effective, sensitive, and efficient solution for the quality control of Palbociclib, contributing to improved therapeutic consistency and patient safety in cancer treatment