A Novel RP-HPLC Method Development and Validation for Determination of Palbociclib drug in tablet Formulation

A concise, reliable, and stability-indicating RP-HPLC method was developed for the quantification of Palbociclib in its tablet dosage form. Using a mobile phase consisting of 0.1% sodium hydrogen phosphate buffer and acetonitrile in a 55:45 (v/v) ratio, the separation was carried out on a BDS C18 column (250 × 4.6 mm, 5 μm). The flow rate was maintained at 1.0ml/min with detection at 225nm, and the column temperature was set to 30°C. Under these conditions, Palbociclib produced a sharp, symmetrical peak with a retention time of 2.19minutes. ICH Q2(R1) recommendations for system appropriateness, specificity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ), and robustness were followed in the methodical validation of the suggested approach. With a correlation coefficient (r²) of 0.999, the method demonstrated linearity in the concentration range of 7.5-45μg/ml. Excellent repeatability and reproducibility were confirmed by the system and method precision %RSD being less than 0.6%. The LOD and LOQ were 0.08 μg/ml and 0.24μg/ml, respectively, indicating good sensitivity, and the mean recovery of 99.61% showed great accuracy. The results were not substantially impacted by intentional changes in chromatographic conditions, demonstrating the method's robustness. The study concludes shows the devised RP-HPLC method is easy to use, quick, accurate, and appropriate for regular quantitative analysis and quality monitoring of pharmaceutical formulations containing palbociclib.