Determination of palbociclib by high performance liquid chromatography

Abstract

In order to establish an HPLC method for the content determination of palbociclib, HPLC is performed on the column of Agilent C18 （250 mm × 4.6 mm,5 μm）with the mobile phase of acetonitrile-water (300∶700,0.1% TFA included) at the flow rate of 1.0 mL/min, with the sample size of 10 μL, the detection wavelength of 234 nm and the column temperature of 40 ℃. The result shows that the main drug and the related substances could be well separated; the calibration curve of palbociclib is in good linearity over the range of 50~150 μg/mL, and r=0.999 5; the RSD of instrument precision, intermediate precision and stability test of related substances and content are no more than 2.0%; the average recovery is 100.0% with RSD of 0.8% (n=9). The method can rapidly and accurately determine the PD content, effectively eliminate the effects of other external factors. It provides a new reference to the content determination of active pharmaceutical ingredients.

Keywords

• chromatography
• palbociclib
• HPLC
• assay
• methodology validation