Sensitive and specific LC-MS assay for quantification of digoxin in human plasma and urine
Digoxin, a commonly prescribed cardiac glycoside with a narrow therapeutic window, is routinely used in pharmacokinetic studies to assess the in vivo activity of the drug efflux pump P‐glycoprotein. To minimize adverse events, a sub‐therapeutic dose of digoxin is usually administered, producing low...
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| Published in | Biomedical chromatography Vol. 22; no. 7; pp. 712 - 718 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Chichester, UK
John Wiley & Sons, Ltd
01.07.2008
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0269-3879 1099-0801 |
| DOI | 10.1002/bmc.988 |
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| Abstract | Digoxin, a commonly prescribed cardiac glycoside with a narrow therapeutic window, is routinely used in pharmacokinetic studies to assess the in vivo activity of the drug efflux pump P‐glycoprotein. To minimize adverse events, a sub‐therapeutic dose of digoxin is usually administered, producing low plasma concentrations requiring a sensitive detection technique. Commonly available immunoassay techniques do not provide the required sensitivity to measure these low plasma concentrations and are potentially non‐specific in certain subject populations. Previously published mass spectrometric techniques require either large plasma volumes or a tandem mass spectrometer. To overcome these challenges we have developed a sensitive and specific LC‐MS method for the quantification of digoxin in small volumes of human plasma and urine. Plasma (1 mL) was extracted with methyl t‐butyl ether under basic conditions followed by LC‐MS detection of the sodium adducts of digoxin (803.4 m/z) and digitoxin (787.4 m/z, internal standard). Linearity and accuracy were demonstrated across a wide range of digoxin plasma concentration (0.05–1.5 ng/mL). This specific, sensitive, validated digoxin LC‐MS assay can be used to quantify sub‐therapeutic digoxin plasma concentrations in men and women (pregnant and non‐pregnant). Copyright © 2008 John Wiley & Sons, Ltd. |
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| AbstractList | Digoxin, a commonly prescribed cardiac glycoside with a narrow therapeutic window, is routinely used in pharmacokinetic studies to assess the
in vivo
activity of the drug efflux pump P‐glycoprotein. To minimize adverse events, a sub‐therapeutic dose of digoxin is usually administered, producing low plasma concentrations requiring a sensitive detection technique. Commonly available immunoassay techniques do not provide the required sensitivity to measure these low plasma concentrations and are potentially non‐specific in certain subject populations. Previously published mass spectrometric techniques require either large plasma volumes or a tandem mass spectrometer. To overcome these challenges we have developed a sensitive and specific LC‐MS method for the quantification of digoxin in small volumes of human plasma and urine. Plasma (1 mL) was extracted with methyl
t
‐butyl ether under basic conditions followed by LC‐MS detection of the sodium adducts of digoxin (803.4
m/z
) and digitoxin (787.4
m/z
, internal standard). Linearity and accuracy were demonstrated across a wide range of digoxin plasma concentration (0.05–1.5 ng/mL). This specific, sensitive, validated digoxin LC‐MS assay can be used to quantify sub‐therapeutic digoxin plasma concentrations in men and women (pregnant and non‐pregnant). Copyright © 2008 John Wiley & Sons, Ltd. Digoxin, a commonly prescribed cardiac glycoside with a narrow therapeutic window, is routinely used in pharmacokinetic studies to assess the in vivo activity of the drug efflux pump P‐glycoprotein. To minimize adverse events, a sub‐therapeutic dose of digoxin is usually administered, producing low plasma concentrations requiring a sensitive detection technique. Commonly available immunoassay techniques do not provide the required sensitivity to measure these low plasma concentrations and are potentially non‐specific in certain subject populations. Previously published mass spectrometric techniques require either large plasma volumes or a tandem mass spectrometer. To overcome these challenges we have developed a sensitive and specific LC‐MS method for the quantification of digoxin in small volumes of human plasma and urine. Plasma (1 mL) was extracted with methyl t‐butyl ether under basic conditions followed by LC‐MS detection of the sodium adducts of digoxin (803.4 m/z) and digitoxin (787.4 m/z, internal standard). Linearity and accuracy were demonstrated across a wide range of digoxin plasma concentration (0.05–1.5 ng/mL). This specific, sensitive, validated digoxin LC‐MS assay can be used to quantify sub‐therapeutic digoxin plasma concentrations in men and women (pregnant and non‐pregnant). Copyright © 2008 John Wiley & Sons, Ltd. Digoxin, a commonly prescribed cardiac glycoside with a narrow therapeutic window, is routinely used in pharmacokinetic studies to assess the in vivo activity of the drug efflux pump P-glycoprotein. To minimize adverse events, a sub-therapeutic dose of digoxin is usually administered, producing low plasma concentrations requiring a sensitive detection technique. Commonly available immunoassay techniques do not provide the required sensitivity to measure these low plasma concentrations and are potentially non-specific in certain subject populations. Previously published mass spectrometric techniques require either large plasma volumes or a tandem mass spectrometer. To overcome these challenges we have developed a sensitive and specific LC-MS method for the quantification of digoxin in small volumes of human plasma and urine. Plasma (1 mL) was extracted with methyl t-butyl ether under basic conditions followed by LC-MS detection of the sodium adducts of digoxin (803.4 m/z) and digitoxin (787.4 m/z, internal standard). Linearity and accuracy were demonstrated across a wide range of digoxin plasma concentration (0.05-1.5 ng/mL). This specific, sensitive, validated digoxin LC-MS assay can be used to quantify sub-therapeutic digoxin plasma concentrations in men and women (pregnant and non-pregnant).Digoxin, a commonly prescribed cardiac glycoside with a narrow therapeutic window, is routinely used in pharmacokinetic studies to assess the in vivo activity of the drug efflux pump P-glycoprotein. To minimize adverse events, a sub-therapeutic dose of digoxin is usually administered, producing low plasma concentrations requiring a sensitive detection technique. Commonly available immunoassay techniques do not provide the required sensitivity to measure these low plasma concentrations and are potentially non-specific in certain subject populations. Previously published mass spectrometric techniques require either large plasma volumes or a tandem mass spectrometer. To overcome these challenges we have developed a sensitive and specific LC-MS method for the quantification of digoxin in small volumes of human plasma and urine. Plasma (1 mL) was extracted with methyl t-butyl ether under basic conditions followed by LC-MS detection of the sodium adducts of digoxin (803.4 m/z) and digitoxin (787.4 m/z, internal standard). Linearity and accuracy were demonstrated across a wide range of digoxin plasma concentration (0.05-1.5 ng/mL). This specific, sensitive, validated digoxin LC-MS assay can be used to quantify sub-therapeutic digoxin plasma concentrations in men and women (pregnant and non-pregnant). Digoxin, a commonly prescribed cardiac glycoside with a narrow therapeutic window, is routinely used in pharmacokinetic studies to assess the in vivo activity of the drug efflux pump P-glycoprotein. To minimize adverse events, a sub-therapeutic dose of digoxin is usually administered, producing low plasma concentrations requiring a sensitive detection technique. Commonly available immunoassay techniques do not provide the required sensitivity to measure these low plasma concentrations and are potentially non-specific in certain subject populations. Previously published mass spectrometric techniques require either large plasma volumes or a tandem mass spectrometer. To overcome these challenges we have developed a sensitive and specific LC-MS method for the quantification of digoxin in small volumes of human plasma and urine. Plasma (1 mL) was extracted with methyl t-butyl ether under basic conditions followed by LC-MS detection of the sodium adducts of digoxin (803.4 m/z) and digitoxin (787.4 m/z, internal standard). Linearity and accuracy were demonstrated across a wide range of digoxin plasma concentration (0.05-1.5 ng/mL). This specific, sensitive, validated digoxin LC-MS assay can be used to quantify sub-therapeutic digoxin plasma concentrations in men and women (pregnant and non-pregnant). |
| Author | Kalhorn, Tom Hebert, Mary Easterling, Tom Kirby, Brian J. Unadkat, Jashvant D. |
| Author_xml | – sequence: 1 givenname: Brian J. surname: Kirby fullname: Kirby, Brian J. organization: Department of Pharmaceutics, University of Washington, Seattle, WA 98195, USA – sequence: 2 givenname: Tom surname: Kalhorn fullname: Kalhorn, Tom organization: Department of Pharmaceutics, University of Washington, Seattle, WA 98195, USA – sequence: 3 givenname: Mary surname: Hebert fullname: Hebert, Mary organization: Department of Pharmacy, University of Washington, Seattle, WA 98195, USA – sequence: 4 givenname: Tom surname: Easterling fullname: Easterling, Tom organization: Department of Obstetrics and Gynecology, University of Washington, Seattle, WA 98195, USA – sequence: 5 givenname: Jashvant D. surname: Unadkat fullname: Unadkat, Jashvant D. email: jash@u.washington.edu organization: Department of Pharmaceutics, University of Washington, Seattle, WA 98195, USA |
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| References | Graves SW, Brown B and Valdes R Jr. An endogenous digoxin-like substance in patients with renal impairment. Annals of Internal Medicine 1983; 99: 604-608. Kirby B, Kharasch ED, Thummel KT, Narang VS, Hoffer CJ and Unadkat JD. Simultaneous measurement of in vivo P-glycoprotein and cytochrome P450 3A activities. Journal of Clinical Pharmacology 2006; 46: 1313-1319. Ikeda Y, Araki T, Takimoto H and Fujii Y. Development of radioimmunoassay for measurement of serum digoxin in digitalized patients using novel anti-digoxin antiserum. Biological and Pharmaceutical Bulletin 2002; 25: 422-425. Tracqui A, Kintz P, Ludes B and Mangin P. High-performance liquid chromatography-ionspray mass spectrometry for the specific determination of digoxin and some related cardiac glycosides in human plasma. Journal of Chromatography B: Biomedical Science Applications 1997; 692: 101-109. Azzazy HM, Duh SH, Maturen A, Schaller E, Shaw L, Grimaldi R, Shock R and Christenson RH. Multicenter study of Abbott AxSYM Digoxin II assay and comparison with 6 methods for susceptibility to digoxin-like immunoreactive factors. Clinical Chemistry 1997; 43: 1635-1640. Dasgupta A, Kang E and Datta P. The new enzyme-linked immunosorbent digoxin assay on the ADVIA integrated modular system is virtually free from oleander interference. Therapeutic Drug Monitoring 2006; 28: 282-285. Cook JD, Koch TR, Cook MS and Knoblock EC. Inaccuracies in digoxin measurement. Clinical Biochemistry 1988; 21: 353-357. Nanji AA and Greenway DC. Falsely raised plasma digoxin concentrations in liver disease. British Medical Journal (Clinical Research Edition), 1985; 290: 432-423. Beyers AD, Spruyt LL, Seifart HI, Kriegler A, Parkin DP and Van Jaarsveld PP. Endogenous immunoreactive digitalis-like substance in neonatal serum and placental extracts. South African Medical Journal 1984; 65: 878-882. Endres CJ, Hsiao P, Chung FS and Unadkat JD. The role of transporters in drug interactions. European Journal of Pharmaceutical Science 2006; 27: 501-517. Diamandis EP, Papanastasiou-Diamandi A and Soldin SJ. Digoxin immunoreactivity in cord and maternal serum and placental extracts. Partial characterization of immunoreactive substances by high-performance liquid chromatography and inhibition of Na+, K+-ATPase. Clinical Biochemistry 1985; 18: 48-55. Ijiri Y, Hayahi T, Ogihara T, Ohi K, Suzuki K, Tamai H, Kitaura Y, Takenaka H and Tanaka K. Increased digitalis-like immunoreactive substances in neonatal plasma measured using fluorescence polarization immunoassay. Journal of Clinical and Pharmaceutical Therapy 2004; 29: 565-571. Salvador A, Sagan C and Denouel J. Rapid quantitation of digoxin in human plasma and urine using isotope dilution liquid chromatography-tandem mass spectrometry. Journal of Liquid Chromatography and Related Technology, 2006; 29: 1917-1932. Yao M, Zhang H, Chong S, Zhu M and Morrison RA. A rapid and sensitive LC/MS/MS assay for quantitative determination of digoxin in rat plasma. Journal of Pharmaceutical and Biomedical Analysis 2003; 32: 1189-1197. Datta P and Dasgupta A. Interference of endogenous digoxin-like immunoreactive factors in serum digoxin measurement is minimized in a new turbidimetric digoxin immunoassay on ADVIA 1650 analyzer. Therapeutic Drug Monitoring 2004; 26: 85-89. Smalley J, Marino AM, Xin B, Olah T and Balimane PV. Development of a quantitative LC-MS/MS analytical method coupled with turbulent flow chromatography for digoxin for the in vitro P-gp inhibition assay. Journal of Chromatography B: Analytical Technology and Biomedical Life Sciences 2007; 854: 260-267. Mitamura K, Horikawa A, Yamane Y, Ikeda Y, Fujii Y and Shimada K. Determination of digoxin in human serum using stable isotope dilution liquid chromatography/electrospray ionization-tandem mass spectrometry. Biological and Pharmaceutical Bulletin 2007; 30: 1653-1656. 2002; 25 1985; 18 1985; 290 2007; 854 2004; 29 1997; 43 2006; 46 1984; 65 2006; 27 1997; 692 2006; 28 2004; 26 1988; 21 2006; 29 2007; 30 2003; 32 1983; 99 Azzazy HM (e_1_2_1_2_1) 1997; 43 e_1_2_1_7_1 e_1_2_1_8_1 e_1_2_1_5_1 e_1_2_1_6_1 e_1_2_1_12_1 e_1_2_1_4_1 e_1_2_1_13_1 e_1_2_1_10_1 e_1_2_1_11_1 Beyers AD (e_1_2_1_3_1) 1984; 65 e_1_2_1_16_1 e_1_2_1_17_1 e_1_2_1_14_1 e_1_2_1_15_1 e_1_2_1_9_1 e_1_2_1_18_1 |
| References_xml | – reference: Kirby B, Kharasch ED, Thummel KT, Narang VS, Hoffer CJ and Unadkat JD. Simultaneous measurement of in vivo P-glycoprotein and cytochrome P450 3A activities. Journal of Clinical Pharmacology 2006; 46: 1313-1319. – reference: Mitamura K, Horikawa A, Yamane Y, Ikeda Y, Fujii Y and Shimada K. Determination of digoxin in human serum using stable isotope dilution liquid chromatography/electrospray ionization-tandem mass spectrometry. Biological and Pharmaceutical Bulletin 2007; 30: 1653-1656. – reference: Datta P and Dasgupta A. Interference of endogenous digoxin-like immunoreactive factors in serum digoxin measurement is minimized in a new turbidimetric digoxin immunoassay on ADVIA 1650 analyzer. Therapeutic Drug Monitoring 2004; 26: 85-89. – reference: Graves SW, Brown B and Valdes R Jr. An endogenous digoxin-like substance in patients with renal impairment. Annals of Internal Medicine 1983; 99: 604-608. – reference: Tracqui A, Kintz P, Ludes B and Mangin P. High-performance liquid chromatography-ionspray mass spectrometry for the specific determination of digoxin and some related cardiac glycosides in human plasma. Journal of Chromatography B: Biomedical Science Applications 1997; 692: 101-109. – reference: Dasgupta A, Kang E and Datta P. The new enzyme-linked immunosorbent digoxin assay on the ADVIA integrated modular system is virtually free from oleander interference. Therapeutic Drug Monitoring 2006; 28: 282-285. – reference: Salvador A, Sagan C and Denouel J. Rapid quantitation of digoxin in human plasma and urine using isotope dilution liquid chromatography-tandem mass spectrometry. Journal of Liquid Chromatography and Related Technology, 2006; 29: 1917-1932. – reference: Beyers AD, Spruyt LL, Seifart HI, Kriegler A, Parkin DP and Van Jaarsveld PP. Endogenous immunoreactive digitalis-like substance in neonatal serum and placental extracts. South African Medical Journal 1984; 65: 878-882. – reference: Ijiri Y, Hayahi T, Ogihara T, Ohi K, Suzuki K, Tamai H, Kitaura Y, Takenaka H and Tanaka K. Increased digitalis-like immunoreactive substances in neonatal plasma measured using fluorescence polarization immunoassay. Journal of Clinical and Pharmaceutical Therapy 2004; 29: 565-571. – reference: Ikeda Y, Araki T, Takimoto H and Fujii Y. Development of radioimmunoassay for measurement of serum digoxin in digitalized patients using novel anti-digoxin antiserum. Biological and Pharmaceutical Bulletin 2002; 25: 422-425. – reference: Diamandis EP, Papanastasiou-Diamandi A and Soldin SJ. Digoxin immunoreactivity in cord and maternal serum and placental extracts. Partial characterization of immunoreactive substances by high-performance liquid chromatography and inhibition of Na+, K+-ATPase. Clinical Biochemistry 1985; 18: 48-55. – reference: Nanji AA and Greenway DC. Falsely raised plasma digoxin concentrations in liver disease. British Medical Journal (Clinical Research Edition), 1985; 290: 432-423. – reference: Smalley J, Marino AM, Xin B, Olah T and Balimane PV. Development of a quantitative LC-MS/MS analytical method coupled with turbulent flow chromatography for digoxin for the in vitro P-gp inhibition assay. Journal of Chromatography B: Analytical Technology and Biomedical Life Sciences 2007; 854: 260-267. – reference: Azzazy HM, Duh SH, Maturen A, Schaller E, Shaw L, Grimaldi R, Shock R and Christenson RH. Multicenter study of Abbott AxSYM Digoxin II assay and comparison with 6 methods for susceptibility to digoxin-like immunoreactive factors. Clinical Chemistry 1997; 43: 1635-1640. – reference: Endres CJ, Hsiao P, Chung FS and Unadkat JD. The role of transporters in drug interactions. European Journal of Pharmaceutical Science 2006; 27: 501-517. – reference: Yao M, Zhang H, Chong S, Zhu M and Morrison RA. A rapid and sensitive LC/MS/MS assay for quantitative determination of digoxin in rat plasma. Journal of Pharmaceutical and Biomedical Analysis 2003; 32: 1189-1197. – reference: Cook JD, Koch TR, Cook MS and Knoblock EC. Inaccuracies in digoxin measurement. 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| Snippet | Digoxin, a commonly prescribed cardiac glycoside with a narrow therapeutic window, is routinely used in pharmacokinetic studies to assess the in vivo activity... Digoxin, a commonly prescribed cardiac glycoside with a narrow therapeutic window, is routinely used in pharmacokinetic studies to assess the in vivo activity... |
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| SubjectTerms | Chromatography, Liquid - methods Digitoxin - blood Digitoxin - chemistry Digitoxin - urine Digoxin - blood Digoxin - chemistry Digoxin - urine digoxin LC-MS assay Female Humans Mass Spectrometry - methods Pregnancy Reproducibility of Results Sensitivity and Specificity |
| Title | Sensitive and specific LC-MS assay for quantification of digoxin in human plasma and urine |
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