Login Register Cart 0
Generic placeholder image

Current Analytical Chemistry

Editor-in-Chief

ISSN (Print): 1573-4110
ISSN (Online): 1875-6727

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Determination of Sufentanil in Human Plasma Using Ultra-high Performance Liquid Chromatography Coupled with Tandem Mass Spectrometry (UPLC–MS/MS)

Author(s): Sang-Min Lee, Suin Kim, Dongseong Shin and Kwang-Hee Shin*

Volume 19, Issue 7, 2023

Published on: 04 September, 2023

Page: [531 - 540] Pages: 10

DOI: 10.2174/1573411019666230823094749

Price: $65

Abstract

Background: Sufentanil, an opioid analgesic, is used as an induction agent for general anesthesia during surgery. Sufentanil is more active than other anesthetics and has a narrow therapeutic range. Therefore, a precise dosage regimen is necessary when administering sufentanil.

Objective: This study aimed to develop a bioanalytical method for the determination of sufentanil within the sensitive concentration range more than that in a previous study utilizing protein precipitation (PP) and determine the plasma concentration of sufentanil.

Methods: A method for quantitating sufentanil was developed using ultra–high performance liquid chromatography coupled with mass spectrometry (UPLC–MS/MS) and detection by electrospray ionization (ESI). The internal standard was sufentanil-d5. Chromatographic separation was performed using an Acquity UPLC HSS T3 column (50 × 2.1 mm, 1.8 μm) from Waters (Milford, MA, USA). Protein precipitation (PP) was used for sample preparation, and gradient elution was conducted using a mobile phase consisting of 1 mL of 2M ammonium acetate in 99% formic acid in 1 L of water or in 1 L of acetonitrile. The total run time for the analysis was 5 min, and the flow rate was 0.4 mL/min.

Results: Standard curves were linear over ranges of 0.025–30 ng/mL for sufentanil with a correlation coefficient (r2) greater than 0.9998. The lower limit of quantification (LLOQ) was 0.025 ng/mL. The intra– and inter–day accuracies were 97.66%–108.8% and 101.25%–103.17%, respectively, and the precision did not exceed 15% for sufentanil.

Conclusion: This study developed a validated, simple, sensitive, and convenient UPLC–MS/MS method for quantifying sufentanil in human plasma. This method was applied to determine sufentanil concentration in the plasma of patients undergoing surgery. The bioanalytical method using PP showed a sufficiently sensitive concentration range. This method could be applied to various pharmacokinetic studies of sufentanil.

« Previous Next »
Graphical Abstract

[1]
Hansdottir, V.; Hedner, T.; Woestenborghs, R.; Nordberg, G. The CSF and plasma pharmacokinetics of sufentanil after intrathecal administration. Anesthesiology, 1991, 74(2), 264-269.
[http://dx.doi.org/10.1097/00000542-199102000-00012] [PMID: 1671323]
[2]
Babazade, R.; Turan, A. Pharmacokinetic and pharmacodynamic evaluation of sublingual sufentanil in the treatment of post-operative pain. Expert Opin. Drug Metab. Toxicol., 2016, 12(2), 217-224.
[http://dx.doi.org/10.1517/17425255.2016.1134487] [PMID: 26799508]
[3]
Mather, L.E. Clinical pharmacokinetics of fentanyl and its newer derivatives. Clin. Pharmacokinet., 1983, 8(5), 422-446.
[http://dx.doi.org/10.2165/00003088-198308050-00004] [PMID: 6226471]
[4]
Monk, J.P.; Beresford, R.; Ward, A. Sufentanil. Drugs, 1988, 36(3), 286-313.
[http://dx.doi.org/10.2165/00003495-198836030-00003] [PMID: 2903821]
[5]
Zawadzki, M.; Kowalski, G. Chłopaś-Konowałek, A.; Siczek, M.; Sobieszczańska, M.; Leppert, W.; Wieczorowska-Tobis, K.; Szpot, P. Rapid determination of sufentanil in human plasma by UHPLC–QqQ-MS-MS. J. Anal. Toxicol., 2021, 45(6), 605-611.
[http://dx.doi.org/10.1093/jat/bkaa123] [PMID: 32901795]
[6]
Pokorná, P.; Šíma, M.; Koch, B.; Tibboel, D. Slanař, O. Sufentanil Disposition and Pharmacokinetic Model-Based Dosage Regimen for Sufentanil in Ventilated Full-Term Neonates. Pharmacology, 2021, 106(7-8), 384-389.
[http://dx.doi.org/10.1159/000515787] [PMID: 34077940]
[7]
Palleschi, L.; Lucentini, L.; Ferretti, E.; Anastasi, F.; Amoroso, M.; Draisci, G. Quantitative determination of sufentanil in human plasma by liquid chromatography–tandem mass spectrometry. J. Pharm. Biomed. Anal., 2003, 32(2), 329-336.
[http://dx.doi.org/10.1016/S0731-7085(03)00110-9] [PMID: 12763543]
[8]
Saari, T.I.; Fechner, J.; Ihmsen, H.; Schüttler, J.; Jeleazcov, C. Determination of total and unbound sufentanil in human plasma by ultrafiltration and LC–MS/MS: Application to clinical pharmacokinetic study. J. Pharm. Biomed. Anal., 2012, 66, 306-313.
[http://dx.doi.org/10.1016/j.jpba.2012.03.050] [PMID: 22522038]
[9]
Flint, R.B.; Bahmany, S.; van der Nagel, B.C.H.; Koch, B.C.P. Simultaneous quantification of fentanyl, sufentanil, cefazolin, doxapram and keto-doxapram in plasma using liquid chromatography-tandem mass spectrometry. Biomed. Chromatogr., 2018, 32(10), e4290.
[http://dx.doi.org/10.1002/bmc.4290] [PMID: 29768657]
[10]
Nosseir, N.S.; Michels, G.; Binder, P.; Wiesen, M.H.J.; Müller, C. Simultaneous detection of ketamine, lorazepam, midazolam and sufentanil in human serum with liquid chromatography–tandem mass spectrometry for monitoring of analgosedation in critically ill patients. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2014, 973, 133-141.
[http://dx.doi.org/10.1016/j.jchromb.2014.10.006] [PMID: 25464106]
[11]
Ahadi, A.; Partoazar, A.; Abedi-Khorasgani, M.H.; Shetab-Boushehri, S.V. Comparison of liquid-liquid extraction-thin layer chromatography with solid-phase extraction-high-performance thin layer chromatography in detection of urinary morphine. J. Biomed. Res., 2011, 25(5), 362-367.
[http://dx.doi.org/10.1016/S1674-8301(11)60048-1] [PMID: 23554712]
[12]
Wu, C.; Tu, X. Biological and fermentative conversion of syngas. In: Handbook of Biofuels Production; , 2016; pp. 335-357.
[http://dx.doi.org/10.1016/B978-0-08-100455-5.00012-6]
[13]
Heydari, R.; Rashidipour, M.; Naleini, N. Determination of efavirenz in plasma by dispersive liquid-liquid microextraction coupled to high-performance liquid chromatography. Curr. Anal. Chem., 2014, 10(2), 280-287.
[http://dx.doi.org/10.2174/15734110113099990003]
[14]
Kyle, P.B. Toxicology: GCMS; Mass spectrometry for the clinical laboratory, 2017, 131-163.
[15]
Polson, C.; Sarkar, P.; Incledon, B.; Raguvaran, V.; Grant, R. Optimization of protein precipitation based upon effectiveness of protein removal and ionization effect in liquid chromatography–tandem mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2003, 785(2), 263-275.
[http://dx.doi.org/10.1016/S1570-0232(02)00914-5] [PMID: 12554139]
[16]
Bioanalytical method validation guidance for industry; U.S. Department of Health and Human Services Food and Drug Administration,, 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry(Accessed Aug 30, 2023)
[17]
Guideline on bioanalytical method validation; Korean Ministry of Food and Drug Safety,, 2013. https://www.mfds.go.kr/brd/m_1060/view.do?seq=13054(Accessed Aug 30, 2023)
[18]
Majors, R. Column pressure considerations in analytical HPLC. LC GC North Am., 2007, 25(11), 1074-1092.
[19]
Lent, E.M.; Maistros, K.J.; Oyler, J.M. In vitro dermal absorption of carfentanil. Toxicol. In Vitro, 2020, 62, 104696.
[http://dx.doi.org/10.1016/j.tiv.2019.104696] [PMID: 31669393]
[20]
Martens-Lobenhoffer, J. Very sensitive and specific determination of sufentanil in human serum applying liquid chromatography–two stage mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2002, 769(2), 227-233.
[http://dx.doi.org/10.1016/S1570-0232(01)00569-4] [PMID: 11996488]
[21]
Murphy, A.T.; Berna, M.J.; Holsapple, J.L.; Ackermann, B.L. Effects of flow rate on high-throughput quantitative analysis of protein-precipitated plasma using liquid chromatography/tandem mass spectrometry. Rapid Commun. Mass Spectrom., 2002, 16(6), 537-543.
[http://dx.doi.org/10.1002/rcm.606] [PMID: 11870891]
[22]
Mistri, H.N.; Jangid, A.G.; Shrivastav, P.S. Liquid chromatography tandem mass spectrometry method for simultaneous determination of antidiabetic drugs metformin and glyburide in human plasma. J. Pharm. Biomed. Anal., 2007, 45(1), 97-106.
[http://dx.doi.org/10.1016/j.jpba.2007.06.003] [PMID: 17628384]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy