A novel rp-hplc method for the estimation of palbociclib in bulk drug & pharmaceutical dosage form

Abstract

A novel, specific, accurate, rugged, precise reversed-phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative determination of Palbociclib in active pharmaceutical ingredients and in its Pharmaceutical dosage form by using Phenomenex Luna C18 (4.6mm x 150mm, 5mm) column with a mobile phase containing a mixture of Acetonitrile and Potassium dihydrogen phosphate buffer adjusted to pH-2.8 with ortho phosphoric acid in the ratio of 25:75%v/v. The flow rate was 1.0 ml/min and effluent were monitored at 220 nm and a peak eluted at 3.174 min and column oven temperature was maintained ambient. Calibration curve was plotted with a range from 10- 30 µg/ml. The LOD and LOQ values of Palbociclib were found to be 1.3µg/ml and 3.9 µg/ml respectively. The percentage recovery of the Palbociclib was found to be within the limits. The developed RP-HPLC method was validated according to the current International Conference on Harmonization (ICH) guidelines for specificity, LOD, LOQ, linearity, accuracy, precision, intermediate precision and robustness. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Palbociclib in bulk drug and in its pharmaceutical dosage form. The proposed method was applied for the analysis of tablet formulations, to improve QC and assure therapeutic efficacy.