Development and Validation of Pomalidomide Determination in Human Plasma by HPLC-MS/MS Method

Abstract

Introduction. B-cell malignancies of the plasma cell leads to the second most spread hematological malignancy disease, called multiple myeloma. Pomalidomide is used in case of previous multiple myeloma ineffective treatment. Pomalidomide is a thalidomide synthetic derived, approved as immunomodulatory drug by the Food and Drug Administration (FDA). Nowadays, detection of pomalidomide in blood plasma by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) is not spread. Moreover, the detection and the experimental setting accumulated data are varying greatly. This investigation provides development and validation of pomalidomide aiming to determine human blood plasma by HPLC-MS/MS method. The samples were processed by methanol protein precipitation.Aim. The aim of this study is to develop a method for the pomalidomide in human plasma by HPLC-MS/MS for pharmacokinetic studies.Materials and methods. Determination of pomalidomide in plasma by HPLC-MS/MS. The samples were processed by methanol protein precipitation.Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, spike recovery, lower limit of quantification, detection limit, carry-over and stability.Conclusion. The method of the determination of pomalidomide in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 1,00 – 500,00 ng/ml. Method could be applied to pomalidomide determination in plasma for PK and BE studies.

Keywords

• помалидомид
• плазма
• вэжх-мс/мс
• валидация
• биоэквивалентность