Content determination of palbociclib capsules

SONG Wei-jie; WANG Zhi; QIU Fei; WANG Li-qiang; LI Wei

Abstract：Objective:To study the content determination method of palbociclib capsules.Methods:Palbociclib capsules were quantitatively determined by high performance liquid chromatography (HPLC).The Kromasil C18 column (250 mm ×4.6 mm,5 μm) was used.The mobile phase consisted of acetonitrile-0.01 mol· L-1 sodium acetate buffer (30∶ 70,0.5％ TEA included).The wavelength was 260 nm.The flow rate was 1.0 mL·min-1 The column temperature was 30 ℃.The content was computed using external reference method of peak area.Results:The calibration curve of palbociclib capsules had good linearity over the range of 0.004 04 ～ 0.020 19 mg·mL-1.The average recoveries of palbociclib capsules at low,middle and high concentrations were 98.5％,99.1％ and 98.5％,respectively.The contents of palbociclib in three batches of samples were 99.3％,99.3％ and 98.9％,respectively.Conclusion:The established method is simple,efficient,accurate and specific for the content determination of palbociclib capsules,which is free of the interference of excipients and can be used for quality control of palbociclib capsules.