Development and validation of Lenalidomide in human plasma by LC-MS/MS

Area of Science:

• Analytical Chemistry
• Pharmacokinetics

Background:

• Lenalidomide is an immunomodulatory drug requiring precise quantification in biological matrices.
• Accurate measurement of Lenalidomide is crucial for pharmacokinetic and bioequivalence studies.

Purpose of the Study:

• To develop and validate a highly sensitive and ultra-fast LC-MS/MS assay for quantifying Lenalidomide in human plasma.

Main Methods:

• Liquid-liquid extraction using ethyl acetate for sample preparation.
• Reversed-phase isocratic elution on a XTerra RP18 column.
• Detection by triple quadrupole mass spectrometry with electrospray ionization in positive mode.

Main Results:

• The assay demonstrated a lower limit of quantification of 9.999 ng/mL.
• Accurate and precise calibration curves were established over a concentration range of 9.999 to 1010.011 ng/mL.
• The method met regulatory requirements for accuracy, precision, and sensitivity.

Conclusions:

• The developed LC-MS/MS method is highly sensitive, rapid, and accurate for Lenalidomide quantification.
• This validated assay is suitable for supporting human pharmacokinetic and bioequivalence studies.