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A sensitive and validated lc-ms/ms method for high-throughput determination of pomalidomide in human plasma and pharmacokinetic studies

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Chinese Chemical Letters 2022年第2期33卷 916-919页

作者： Chang Shu Teng-Fei Li Duo Li Zhong-Qiu Li Xing-Hua Xia State Key Laboratory of Analytical Chemistry for Life Science School of Chemistry and Chemical EngineeringNanjing UniversityNanjing 210023China Department of Pharmaceutical Analysis School of PharmacyChina Pharmaceutical UniversityNanjing 210009China School of Pharmacy Department of Clinical PharmacologySir Run HospitalNanjing Medical UniversityNanjing 211166China

Pomalidomide is an immunomodulatory agent (IMiD) that has been approved by the US Food and Drug Administration (FDA) for clinical treatment of patients with multiple *** this work,we developed a sensitive and validated lc-ms/ms method for high-throughput determination of pomalidomide over the range of 1.006-100.6 ng/mL(R^(2)=0.9991) in human plasma and pharmacokinetic studies.A liquid-liquid extraction method using ethyl acetate was applied to extract pomalidomide and afatinib (as an internal standard,IS) from human *** separation was performed on a Hedera ODS column (150 mm×2.1 mm,5μm) with security guard C18 column (4 mm×2.0 mm) at 40℃.Methanol and 10 mmol/L aqueous solution of ammonium acetate containing 0.1%formic acid were used as a gradient elution mobile phase,and the flow rate was 0.4 mL/min.A triple quadruple tandem mass spectrometer using multiplex reaction monitoring mode (MRM) with electrospray ionization (ESI) positive ionization was *** precursor to product ion transitions for the quantitative analysis of pomalidomide and the IS were m/z 274.2→163.1 and m/z 486.1→371.1,*** established method has been validated according to regulatory guideline,and the results were all within the acceptance *** validated lc-ms/ms method was successfully applied to analyze samples obtained from clinical pharmacokinetics study after oral administration of pomalidomide (4 mg) capsules in human.

关键词： Pomalidomide Liquid-liquid extraction lc–ms/ms method Pharmacokinetic Human plasma

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