Development and validation of HPLC method for quantifying anticancer agent in pharmaceutical formulation

Palbociclib is a selective cyclin-dependent kinase (CDK) 4/6 inhibitor which is widely used in the treatment of hormone receptor-positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer. In recent years, targeted anticancer therapies such as CDK inhibitors have gained significant importance due to their improved effectiveness and reduced side effects compared to conventional chemotherapy. Therefore, the development of reliable and accurate analytical methods for the estimation of such drugs in pharmaceutical dosage forms is essential to ensure their quality, safety, and efficacy. High performance liquid chromatography (HPLC) is one of the most commonly used analytical techniques in pharmaceutical analysis because of its high sensitivity, precision, and reproducibility. The present study was undertaken to develop and validate a simple, rapid, precise, accurate, and economical reverse phase HPLC (RP-HPLC) method for the quantitative estimation of Palbociclib in pharmaceutical capsule dosage form.Chromatographic separation of Palbociclib was achieved using a C18 column with an optimized mobile phase consisting of suitable organic solvent and buffer in appropriate proportion. The flow rate and detection wavelength were optimized to obtain a sharp and symmetrical peak with good resolution. The detection of Palbociclib was carried out using a UV detector.