Abstract

An LC-MS/MS method is needed to accurately measure the concentration of selpercatinib in a biological sample. This method should be both specific and sensitive. The processed materials were separated using a Zorbax SB-C18 column (50 mm × 4.6 mm) 3.5 μm with a mobile phase of acetonitrile, methanol, and 0.1% HCOOH in the proportion of 20:70:10. The mobile phase was measured using a column with 0.7ml/minute rate of flow. The drug and internal standard, ibrutinib were assessed by monitoring the transitions of m/z –526.25/450.16 and 441.20/55.01 for selpercatinib and IS, correspondingly, in multiple reaction monitoring mode. The linearity line and correlation coefficient (r2) values were y = 0.0012x - 0.0378 and >0.99, correspondingly. For the QC samples (253, 1,800, and 2,700 ng/ml), the %RSD of inter and intraday precision of the developed method ranged from 2.41% to 5.23%. The proposed method was developed and validated as per the regulatory guidelines.

Key words: Selpercatinib, Cancer, LC-MS/MS, Linearity, Accuracy.