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Development and validation of a liquid chromatography-tandem mass spectrometric method for the determination of lenalidomide in human plasma and its application on bioequivalence studies

Authors
  • Gopinath, R.1
  • Narenderan, S. T.2
  • Kumar, M.1
  • Babu, B.2
  • 1 Vinayaka Mission’s Research Foundation (Deemed to be university), Salem, Tamilnadu, 636308, India , Salem (India)
  • 2 JSS College of Pharmacy, Udhagamandalam (Constituent college of JSS Academy of Higher Education & Research), The Nilgiris, Tamilnadu, 643001, India , The Nilgiris (India)
Type
Published Article
Journal
Journal of Analytical Science and Technology
Publisher
Springer Berlin Heidelberg
Publication Date
Nov 28, 2019
Volume
10
Issue
1
Identifiers
DOI: 10.1186/s40543-019-0195-z
Source
Springer Nature
Keywords
License
Green

Abstract

A simple, sensitive, and specific liquid chromatography-tandem mass spectrophotometry (LC-MS/MS) method was developed and validated for the quantification of lenalidomide in human plasma. The separation was carried out on a symmetry, C18, 5-μm (50 × 4.6 mm) column as stationary phase and with an isocratic mobile phase of 0.1% formic acid in water-methanol in the ratio of (15:85, v/v) at a flow rate of 0.5 mL/min. Protonated ions formed by electrospray ionization in the positive mode were used to detect analyte and fluconazole (internal standard). The mass detection was made by monitoring the fragmentation of m/z 260.1/148.8 for lenalidomide and m/z 307.1/238.0 for internal standard on a triple quadrupole mass spectrometer. The developed method was validated over the concentration range of 10–1000 ng/mL for lenalidomide in human plasma with a correlation coefficient (r2) was 0.9930. The accuracy and precision values obtained from six different sets of quality control samples analyzed on separate occasions ranged from 99.41 to 106.97% and 2.88 to 4.22%, respectively. Mean extraction recoveries were 98.06% and 88.78% for the analyte and IS, respectively. The developed method was successfully applied for analyzing lenalidomide in human plasma samples.

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