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BACKGROUND: An ultra performance liquid chromatography-tandem mass spectrometric method was developed and validated for estimation of lenalidomide in human K3EDTA plasma, using lenalidomide 13C5 as an internal standard. In Discovery® HS F5 (5 cm × 4.6 mm, 5 µm) column, chromatographic separation has been achieved with total analysis time 2.5 min using isocratic flow (0.5 mL/min) of mobile phase [acetonirile-10 mM ammonium formate, 80:20, v/v].
METHODS: Lenalidomide and Lenalidomide 13C5 was extracted from human plasma by solid phase extraction technique. Electrospray ionization (ESI) was used for soft ionization technique. Mass transitions of m/z m/z 260.1→149.1 (lenalidomide) and 265.0→149.1(lenalidomide 13C5) were monitored in positive multiple reaction monitoring (+MRM). Within the validated calibration curve range (2.03-1203.02 ng/mL; r >0.999), negligible matrix effect was observed in different types of plasma (normal/hemolyzed/lipemic).
RESULTS: The estimated% ion-suppression for lenalidomide is 2.92% and it had no impact on incurred samples analysis. At lower limit of quantification level, the intra-and inter-day precision values were within 4.67% and 3.90%, respectively.
CONCLUSION: In healthy Indian volunteer, bioequivalence studies were conducted for 25 mg Lenalidomide capsule under fasting and fed conditions and the validated UPLC-MS/MS method was successfully applied for estimation of Lenalidomide in incurred (unknown) samples.
