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An UPLC-MS/MS Method for Routine Quantification of Insulin Degludec in Plasma

Author(s):

Yudong Zhang, Yue Jiang, Ya Wang, Ling Wang, Weijie Han, Xiaoyi Cheng, Xue Deng, Chunmeng Qin and Yan Liu*   Pages 1 - 7 ( 7 )

Abstract:


Background: Chromatographic methods for determination of insulin degludec in rabbit plasma by Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry were developed.

Methods: Analytes were eluted from Waters ACQUITY UPLC® Peptide BEH C18(2.1×50mm,300Å)column with mobile phase of water containing 0.1% formic acid (A) and acetonitrile containing 0.1% formic acid (B). Quantitation of insulin degludec was performed using 1222.06 > 641.24 m/z on multiple-reaction monitoring (MRM) mode.

Results: Good linearity was observed in the concentration range of 500-50000 ng/mL (r >0.99), and the lower limit of quantification was 500ng/mL. The within-run and between-run precision (expressed as relative standard deviation, RSD) of insulin degludec were ≤ 14.16% and ≤ 13.64% respectively, and the accuracy was within 94.37-96.35%. The recovery and matrix effect were both within acceptable limits.

Conclusions: This method was successfully applied for the pharmacokinetic study of insulin degludec in rabbit after subcutaneous administration.

Keywords:

Insulin degludec, Insulin glargine, UPLC-MS/MS, Diabetes, method validation, rabbit plasma

Affiliation:

Pharmacy School, Chongqing Medical University, Chongqing, 400016, Pharmacy School, Chongqing Medical University, Chongqing, 400016, Chongqing Medleader BioPharm Co., Ltd. Science and Technology Incubative Building, Chongqing, Maliu Riverside Development Zone, Chongqing ,404100, Chongqing Medleader BioPharm Co., Ltd. Science and Technology Incubative Building, Chongqing, Maliu Riverside Development Zone, Chongqing ,404100, Pharmacy School, Chongqing Medical University, Chongqing, 400016, Pharmacy School, Chongqing Medical University, Chongqing, 400016, Pharmacy School, Chongqing Medical University, Chongqing, 400016, Pharmacy School, Chongqing Medical University, Chongqing, 400016, Pharmacy School, Chongqing Medical University, Chongqing, 400016



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