Pharmacokinetic Study and Incurred Sample Stability of Esomeprazole in Dried Blood Spot Sample Using High Performance Liquid Chromatography-Photodiode Array
Yahdiana Harahap(1*), Anja Tamabri(2), Vicha Vicha(3), Herman Suryadi(4), Sunarsih Sunarsih(5), Callista Andinie Mulyadi(6)
(1) Faculty of Pharmacy, Universitas Indonesia, Depok 16424, West Java, Indonesia
(2) Faculty of Pharmacy, Universitas Indonesia, Depok 16424, West Java, Indonesia
(3) Faculty of Pharmacy, Universitas Indonesia, Depok 16424, West Java, Indonesia
(4) Faculty of Pharmacy, Universitas Indonesia, Depok 16424, West Java, Indonesia
(5) Dea Medika Clinic, Jl. Bina Marga No. 7, Gunung Putri, Bogor 16961, West Java, Indonesia
(6) Faculty of Pharmacy, Universitas Indonesia, Depok 16424, West Java, Indonesia
(*) Corresponding Author
Abstract
Keywords
Full Text:
Full Text PDFReferences
[1] Food and Drug Administration, 2014, NEXIUM (esomeprazole magnesium) delayed-release capsules, for oral use, Reference ID: 3675799, Food and Drug Administration, U.S. Department of Health and Human Services, USA.
[2] Xu, Y., Fang, W., Zeng, W., Leijen, S., and Woolf, E.J., 2012, Evaluation of dried blood spot (DBS) technology versus plasma analysis for the determination of MK-1775 by HILIC-MS/MS in support of clinical studies, Anal. Bioanal. Chem., 404 (10), 3037–3048.
[3] Li, W., and Lee, M.S., 2014, Dried Blood Spots: Applications and Techniques, John Wiley & Sons, Inc., Hoboken, New York.
[4] Zakaria, R., Allen, K.J., Koplin, J.J., Roche, P., and Greaves, R.F., 2016, Advantages and challenges of dried blood spot analysis by mass spectrometry across the total testing process, EJIFCC, 27 (4), 288–317.
[5] Sharma, A., Jaiswal, S., Shukla, M., and Lal, J., 2014, Dried blood spots: Concepts, present status, and future perspectives in bioanalysis, Drug Test. Anal., 6 (5), 399–414.
[6] Hasselgren, G., Hassan-Alin, M., Andersson, T., Claar-Nilsson, C., and Röhss, K., 2001, Pharmacokinetic study of esomeprazol in the elderly, Clin. Pharmacokinet., 40 (2), 145–150.
[7] Harahap, Y., Baskara, A.E., and Harmita, 2017, Method validation of esomeprazol analysis in human plasma using high performance liquid chromatography–photodiode array, J. Young Pharm., 9 (Suppl. 1), s24–s28.
[8] Wen, Z., Huang, Y., Behler, N., Bambal, R., Bhoopathy, S., and Owen, A., 2010, Determination of red blood cell partitioning and whole blood to plasma ratio using human, rat, and mouse blood: Methods, model-compounds, and specific differences, Absorption Systems, Exton, Pennsylvania, USA.
[9] Reddy, P., Sait, S., Vasudevmurthy, G., Vishwanath, B., Prasad, V., and Reddy, S.J., 2011, Stability indicating simultaneous estimation of assay method for naproxen and esomeprazole in pharmaceutical formulations by RP-HPLC, Der Pharma Chemica, 3 (6), 553–564.
[10] Lowes, S., LeLacheur, R., Shoup, R., Garofolo, F., Dumont, I., Martinez, S., Zimmer, J., Caturla, M.C., Couerbe, P., Awaiye, K., Fatmi, S., Farmen, R., Sheldon, C., Bower, J., Fiscella, M., Fast, D., Cape, S., Hulse, J., Kamerud, J., Zhang, T., Pasas-Farmer, S., Garofolo, W., Moussallie, M., Rocci, M., Allinson, J., Gouty, D., Buonarati, M., Boudreau, N., Pellerin, B., Lin, J., Xu, A., Hayes, R., Bouhajib, M., Stipancic, M., Nicholson, R., Nehls, C., Warren, M., Karnik, S., Houghton, R., Stovold, C., Reuschel, S., Cojocaru, L., Marcelletti, J., Fang, X., Smith, I., and Watson, A., 2014, Recommendations on incurred sample stability (ISS) by GCC, Bioanalysis, 6 (18), 2385–2390.
[11] Es’haghi, Z., 2011, “Photodiode array detection in clinical applications: Quantitative analyte assay advantages, limitations, and disadvantages” in Photodiodes—Communications, Bio-Sensings, Measurements and High-Energy Physics, Chapter 9, Eds. Shi, J.W., InTechOpen, New York.
[12] Committee for Medicinal Products for Human Use (CHMP), 2011, Guideline on bioanalytical method validation, European Medicines Agency London, UK.
[13] United States Food and Drug Administration, 2013, Guidance for industry. Bioanalytical method validation, U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), and Center for Veterinary Medicine (CVM), USA.
[14] Koster, R.A., Greijdanus, B., Alffenaar, J.W., and Touw, D.J., 2015, Dried blood spot analysis of creatinine with LC-MS/MS in addition to immunosuppressants analysis, Anal. Bioanal. Chem., 407 (6), 1585–1594.
[15] Hielscher Ultrasound Technology, 2018, Probe-type sonication vs. ultrasonic bath: An efficiency comparison, https://www.hielscher.com/probe-type-sonication-vs-ultrasonic-bath-an-efficiency-comparison.html, accessed on 7 December 2018.
[16] Lad, R., 2010, Validation of individual quantitative methods for determination of cytochrome P450 probe substrates in human dried blood spots with KCKT–MS/MS, Bioanalysis, 2 (11), 1849–1861.
[17] Wilhelm, A.J., den Burger, J.C., and Swart, E.L., 2014, Therapeutic drug monitoring by dried blood spot: Progress to date and future directions, Clin. Pharmacokinet., 53 (11), 961–973.
[18] Committee for Medicinal Products for Human Use (CHMP), 2010, Guideline on the investigation of bioequivalence (Rev. 1), European Medicines Agency, London, United Kingdom.
[19] Déglon, J., Thomas, A., Mangin, P., and Staub, C., 2011, Direct analysis of dried blood spots coupled with mass spectrometry: Concepts and biomedical applications, Anal. Bioanal. Chem., 402 (8), 2485–2498.
[20] Chunduri, R.H.B., and Dannana, G.S., 2016, Development and validation of a high throughput UPLC–MS/MS method for simultaneous quantification of esomeprazol, rabeprazole, and levosulpiride in human plasma, J. Pharm. Anal., 6 (3), 190–198.
DOI: https://doi.org/10.22146/ijc.42404
Article Metrics
Abstract views : 4191 | views : 2597Copyright (c) 2020 Indonesian Journal of Chemistry
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Indonesian Journal of Chemistry (ISSN 1411-9420 /e-ISSN 2460-1578) - Chemistry Department, Universitas Gadjah Mada, Indonesia.
View The Statistics of Indones. J. Chem.