Feng ZHANG
Shanghai Changzheng Hospital, China
Title: LC–MS/MS method for simultaneous determination of thalidomide, lenalidomide, cyclophosphamide, bortezomib, dexamethasone andadriamycin in serum of multiple myeloma patients
Biography
Biography: Feng ZHANG
Abstract
Multiple myeloma (MM), a malignant neoplastic serum-cell disorder, has been a serious threat to human health. Determination of 6 commonly used drug concentrations, including thalidomide (THD), lenalidomide (LND), cyclophosphamide (CTX), bortezomib (BTZ), dexamethasone (DXM) and adriamycin (ADM), in MM patients was of great clinical interest. Drug pharmacokinetic monitoring was important to ensure safety and efficacy during chemotherapy. We reported a method for the rapid and simultaneous measurement of the above therapeutics by liquid chromatography-tandem mass spectroscopy (LC–MS/MS) method with solid phase extraction. Analysis was performed on a Waters XBridge®BEH C18 column (2.5 μm, 2.1mm × 50 mm), with formic acid aqueous solution and acetonitrile as the mobile phase at flow rate 0.3 mL/min. All analytes showed good correlation coefficients (r > 0.996), and LLOQ of THD, LND, CTX, BTZ, DXM and ADM were 4, 2, 2, 2, 2 and 2 ng/mL, respectively. The inter- and intra-day precisions and stability were expressed as variation coefficients within 15% and relative error less than 15%. Dilution effect, carryover and incurred sample reanalysis were in the acceptable levels. Method validation was investigated according to the 2015 edition Chinese Pharmacopoeia guidelines, as US FDA (2013, revision 1) required. The descried method was successfully applied to determine the clinical incurred serum samples from MM patients, and the tested results were also provided to the doctors for consideration. The LC–MS/MS based assay may improve future clinical studies evaluating common therapeutics for MM treatment.