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Current Pharmaceutical Analysis

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ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

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Research Article

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*

Volume 16, Issue 6, 2020

Page: [792 - 799] Pages: 8

DOI: 10.2174/1573412915666190304145149

Price: $65

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 a 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 effects 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.

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[1]
Dong, S.; Gu, Y.; Wei, G.; Si, D.; Liu, C. Direct comparison of LC-MS/MS and RIA methods for the pharmacokinetics assessment of human insulin in preclinical development. Biomed. Chromatogr., 2018, 32(11) e4323
[http://dx.doi.org/10.1002/bmc.4323] [PMID: 29920712]
[2]
Xu, Y.; Prohn, M.; Cai, X.; Crutchlow, M.; Shankar, S.S.; Bateman, K.; Woolf, E.J. Direct comparison of radioimmunoassay and LC-MS/MS for PK assessment of insulin glargine in clinical development. Bioanalysis, 2014, 6(24), 3311-3323.
[http://dx.doi.org/10.4155/bio.14.219] [PMID: 25534788]
[3]
Haahr, H.; Heise, T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin. Pharmacokinet., 2014, 53(9), 787-800.
[http://dx.doi.org/10.1007/s40262-014-0165-y] [PMID: 25179915]
[4]
Kawaguchi, Y.; Sawa, J.; Sakuma, N.; Kumeda, Y. Efficacy and safety of insulin glargine 300 U/mL versus insulin degludec in patients with type 2 diabetes: a randomized, open-label, crossover study using continuous glucose monitoring profiles. J. Diabetes Investig., 2018, 10, 001-009.
[5]
Freemantle, N.; Chou, E.; Frois, C.; Zhuo, D.; Lehmacher, W.; Vlajnic, A.; Wang, H.; Chung, H.W.; Zhang, Q.; Wu, E.; Gerrits, C. Safety and efficacy of insulin glargine 300 u/mL compared with other basal insulin therapies in patients with type 2 diabetes mellitus: a network meta-analysis. BMJ Open, 2016, 6(2) e009421
[http://dx.doi.org/10.1136/bmjopen-2015-009421] [PMID: 26880669]
[6]
Blackburn, M. Advances in the quantitation of therapeutic insulin analogues by LC-MS/MS. Bioanalysis, 2013, 5(23), 2933-2946.
[http://dx.doi.org/10.4155/bio.13.257] [PMID: 24295119]
[7]
Yalow, R.S.; Berson, S.A. Assay of plasma insulin in human subjects by immunological methods. Nature, 1959, 184(Suppl. 21), 1648-1649.
[http://dx.doi.org/10.1038/1841648b0] [PMID: 13846363]
[8]
Sakamoto, S.; Putalun, W.; Vimolmangkang, S.; Phoolcharoen, W.; Shoyama, Y.; Tanaka, H.; Morimoto, S. Enzyme-linked immunosorbent assay for the quantitative/qualitative analysis of plant secondary metabolites. J. Nat. Med., 2018, 72(1), 32-42.
[http://dx.doi.org/10.1007/s11418-017-1144-z] [PMID: 29164507]
[9]
Rauh, M. LC-MS/MS for protein and peptide quantification in clinical chemistry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2012, 883-884, 59-67.
[http://dx.doi.org/10.1016/j.jchromb.2011.09.030] [PMID: 22000960]
[10]
Li, W.; Zhang, J.; Tse, F.L. Strategies in quantitative LC-MS/MS analysis of unstable small molecules in biological matrices. Biomed. Chromatogr., 2011, 25(1-2), 258-277.
[http://dx.doi.org/10.1002/bmc.1572] [PMID: 21204113]
[11]
Yi, Z.; Luo, M.; Mandarino, L.J.; Reyna, S.M.; Carroll, C.A.; Weintraub, S.T. Quantification of phosphorylation of insulin receptor substrate-1 by HPLC-ESI-MS/MS. J. Am. Soc. Mass Spectrom., 2006, 17(4), 562-567.
[http://dx.doi.org/10.1016/j.jasms.2005.12.010] [PMID: 16503154]
[12]
Thomas, A.; Schänzer, W.; Thevis, M. Determination of human insulin and its analogues in human blood using liquid chromatography coupled to ion mobility mass spectrometry (LC-IM-MS). Drug Test. Anal., 2014, 6(11-12), 1125-1132.
[http://dx.doi.org/10.1002/dta.1710] [PMID: 25219675]
[13]
Langlais, P.; Mandarino, L.J.; Yi, Z. Label-free relative quantification of co-eluting isobaric phosphopeptides of insulin receptor substrate-1 by HPLC-ESI-MS/MS. J. Am. Soc. Mass Spectrom., 2010, 21(9), 1490-1499.
[http://dx.doi.org/10.1016/j.jasms.2010.05.009] [PMID: 20594869]
[14]
Sarmento, B.; Ribeiro, A.; Veiga, F.; Ferreira, D. Development and validation of a rapid reversed-phase HPLC method for the determination of insulin from nanoparticulate systems. Biomed. Chromatogr., 2006, 20(9), 898-903.
[http://dx.doi.org/10.1002/bmc.616] [PMID: 16389645]
[15]
Delavenne, X.; Moracchini, J.; Laporte, S.; Mismetti, P.; Basset, T. UPLC MS/MS assay for routine quantification of dabigatran - a direct thrombin inhibitor - in human plasma. J. Pharm. Biomed. Anal., 2012, 58, 152-156.
[http://dx.doi.org/10.1016/j.jpba.2011.09.018] [PMID: 21996066]
[16]
Dong, S.; Gu, Y.; Wei, G.; Si, D.; Liu, C. Determination of liraglutide in rat plasma by a selective liquid chromatography-tandem mass spectrometry method: Application to a pharmacokinetics study. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2018, 1091, 29-35.
[http://dx.doi.org/10.1016/j.jchromb.2018.05.020] [PMID: 29803687]
[17]
Guidelines, FDA Bioanalytical Method Validation Guidance for Industry, 2018.

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