Preview

Разработка и регистрация лекарственных средств

Расширенный поиск

СПОСОБЫ СТАБИЛИЗАЦИИ ЛЕКАРСТВЕННЫХ ВЕЩЕСТВ И ИХ МЕТАБОЛИТОВ В БИОЛОГИЧЕСКИХ ЖИДКОСТЯХ ПРИ БИОАНАЛИТИЧЕСКИХ ИССЛЕДОВАНИЯХ (ОБЗОР)

Полный текст:

Аннотация

В статье рассмотрены основные способы предотвращения разложения химически нестабильных лекарственных веществ и их метаболитов в биологических жидкостях в процессе хранения после отбора у пациентов, что необходимо для точного количественного определения данных соединений.

Об авторах

И. И. Яичков
ФГБОУ ВО «Ярославский государственный медицинский университет» Минздрава России
Россия


А. Л. Хохлов
ФГБОУ ВО «Ярославский государственный медицинский университет» Минздрава России
Россия


Ю. А. Джурко
ООО «Квинта-Аналитика Ярославль»
Россия


Л. Н. Шитов
ООО «Квинта-Аналитика Ярославль»
Россия


А. А. Трубников
ФГБОУ ВО «Ярославский государственный медицинский университет» Минздрава России
Россия


Список литературы

1. D. Dell. Labile Metabolites // Chromatographia Supplement. 2004. № 59. С. 139-148.

2. M. Hilhorst et al. Stabilization of clinical samples collected for quantitative bioanalysis - a reflection from the European Bioanalysis Forum // Bioanalysis. 2015. № 3 (7). Р. 333-343.

3. Guideline on validation of bioanalytical methods (draft). European Medicines Agency, Committee for medicinal products for human use, London, 2013.

4. А.Н. Миронов. Руководство по экспертизе лекарственных средств. Т. 1. - М.: Гриф и К. 2013. 322 с.

5. Решение Совета Евразийской экономической комиссии от 3 ноября 2016 г. № 85 «Об утверждении Правил проведения исследований биоэквивалентности лекарственных препаратов в рамках Евразийского экономического союза», 2016.

6. Органическая химия. Кн.1: Основной курс / Под ред. Н.А. Тюкавкиной. - М.: Дрофа. 2003. 640 с.

7. A.L. Khokhlov et al. The Pharmacokinetic Properties and Bioequivalence of Methyldopa Formulations: Results of an Openlabel, Randomized, Two-period, Crossover, Single-dose Study // Journal of Bioequivalence & Bioavailability. 2016. № 8. P. 185-190.

8. N.C. van de Merbel et al. Quantitative determination of free and total dopamine in human plasma by LC-MS/MS: the importance of sample preparation // Bioanalysis. 2011. № 3(17). P. 1949-1961.

9. W. Li et al. Handbook of LC-MS Bioanalysis. - New Jersey: Jonh Wiley and Sons. 2013. 675 p.

10. H. Tomšíková. Determination of pteridines in biological samples with an emphasis on their stability // Bioanalysis. 2013. № 5(18). P. 2307-2326.

11. D.W. Howells, K. Hyland. Direct analysis of tetrahydrobiopterin in cerebrospinal fluid by high-performance liquid chromatography with redox electrochemistry: prevention of autoxidation during storage and analysis // Clinica Chimica Acta. 1987. V. 167. P. 23-30.

12. B. Fiege et al. Plasma tetrahydrobiopterin and its pharmacokinetic following oral administration // Molecular Genetics and Metabolism. 2004. V. 81. P. 45-51.

13. E.R. Wickremsinhe et al. Stereoselective Metabolism of Prasugrel in Humans Using a Novel Chiral Liquid Chromatography-Tandem Mass Spectrometry Method // Drug Metobalism and Disposition. 2007. № 6(35). P. 917-921.

14. K.H. Abu-Shandi, E. Redel. Quantification and Stability Evaluation of the Highly Specific Angeotensin-Converting Enzyme (ACE) Inhibitor in Human Plasma Using a Gas Chromatography Method with N,N,N’,N’-teteramethyl- 2-butenediamine Derivatizing Agent // Jordan Journal of Chemistry. 2009. № 2(4). P. 183-194.

15. M. Jemal et al. LC/MS/MS Determination of Omapatrilat, a Sulfhydryl-Containing Vasopeptidase Inhibitor, and Its Sulfhydryl- and Thioether-Containing Metabolites in Human Plasma // Analytical Chemistry. 2001. № 22(73). Р. 5450-5456.

16. N.C. Van de Merbel et al. A validated liquid chromatography-tandem mass spectrometry method for the quantitative determination of 4β-hydroxycholesterol in human plasma // Journal of Pharmaceutical and Biomedical Analysis. 2011. V. 55. Р. 1089-1095.

17. M.Y. Katteboina, N.R. Pilli, S.R. Salta. LC-MS/MS Method Development and Validation of Montelukast in human plasma and its clinical application// American Journal of Pharmaceutical Research. 2015. № 5 (3). Р. 646-657.

18. Z. Bartoszewicz et al. Can we accurately measure the concentration of clinically relevant vitamin D metabolites in the circulation? The problems and their consequences // Endokrynologia Polska. 2013. № 3(64). P. 238-245.

19. A. Fura et al. Shift in pH of biological fluids during storage and processing: effect on bioanalysis // Journal of Pharmaceutical and Biomedical Analysis. 2003. V. 32. P. 513-522.

20. T. Ebner et al. Disposition and Chemical stability of Telmisartan 1-O-acylglucuronide // Drug Metabolism and Disposition. 1999. № 10(27). Р. 1143-1149.

21. C.K. Hull et al. Quantif ication of rosuvastatin in human plasma by automated solid-phase extraction using tandem mass spectrometric detection // Journal of Chromatography B. 2002. V. 772. P. 219-228.

22. D. Mulvana, M. Jemal , S.C. Pulver. Quantitative determination of pravastatin and its biotransformation products in human serum by turbo ion spray LC/ MS/MS // Journal of Pharmaceutical and Biomedical Analysis. 2000. № 23. Р. 851-866.

23. M. Jemal et al. Quantitation of the Acid and Lactone Forms of Atorvastatin and its Biotransformation Products in Human Serum by High-performance Liquid Chromatography with Electrospray Tandem Mass Spectrometry // Rapid Communications in Mass Spectrometry. 1999. V. 13. P. 1003-1015.

24. M. Jemal, Z. Ouyang, M.L. Powell. Direct-injection LC-MS-MS method for high-throughput simultaneous quantitation of simvastatin and simvastatin acid in human plasma // Journal of Pharmaceutical and Biomedical Analysis. 2000. V. 23. P. 323-340.

25. E.N. Fung et al. Effective screening approach to select esterase inhibitors used for stabilizing ester-containing prodrugs analyzed by LC-MS/MS // Bioanalysis. 2010. № 2(4). Р. 733-743.

26. Z. Suchocka et al. RP-HPLC determination of paraoxonase 3 activity in human blood serum // Journal of Pharmaceutical and Biomedical Analysis. 2006. V. 42. P. 113-119.

27. N. Lindegardh et al. Importance of Collection Tube during Clinical Studies of Oseltamivir // Antimicrobial Agents and Chemotherapy. 2007. № 5(51). P. 1835-1836.

28. J. Zeng et al. Simultaneous determination of a selective adenosine 2A agonist, BMS-068645, and its acid metabolite in human plasma by liquid chromatography-tandem mass spectrometry - Evaluation of the esterase inhibitor, diisopropyl fluorophosphate, in the stabilization of a labile ester-containing drug // Journal of Chromatography B. 2007. V. 852. P. 77-84.

29. B. Nigori et al. Simulation extraction of acetylsalicylic acid and Salicylic acid from human plasma and simultaneous estimation by liquid chromatography and atmospheric pressure chemical ionization / tandem massspectrometry detection // Arzneimittelforschung. 2011. № 5(61). P 301-311.

30. S.K. Bae et al. Determination of acetylsalicylic acid and its major metabolite, salicylic acid in human plasma using liquid chromatography - tandem massspectrometry: application to pharmacokinetic study of Astrix in Korean healthy volunteers // Biomedical Chromatography. 2008. V. 22. P. 590 -595.

31. X. Xu et al. Rapid and sensitive Determination of acetylsalicylic acid and salicylic acid in plasma using liquid chromatography - tandem massspectrometry: application to pharmacokinetic study // Biomedical Chromatography. 2009. V. 23. P. 973-979.

32. C. Pham-Huy, G. Villain-Pautet, H. Hua. Separation of oxazepam, lorazepam, and temazepam enantiomers by HPLS on a derivatizated cyclodextrin-bonded phase: application to the determination of oxazepam in plasma // Biochemical and biophysical methods. 2002. V. 54. P. 287-299.

33. B. Jamali et al. Investigation of racemisation of the enantiomers of glitazone drug compounds at different pH using chiral HPLC and chiral CE // Journal of Pharmaceutical and Biomedical Analysis. 2008. V. 46. P. 82-87.

34. C.J. Wang et al. Novel inhibition of cis/trans retinoic acid interconversion in biological fluids - an accurate method for determination trans and 13-cis retinoic acid in biological fluids // Journal of Chromatography B. 2003. V. 796. P. 283-291.


Для цитирования:


Яичков И.И., Хохлов А.Л., Джурко Ю.А., Шитов Л.Н., Трубников А.А. СПОСОБЫ СТАБИЛИЗАЦИИ ЛЕКАРСТВЕННЫХ ВЕЩЕСТВ И ИХ МЕТАБОЛИТОВ В БИОЛОГИЧЕСКИХ ЖИДКОСТЯХ ПРИ БИОАНАЛИТИЧЕСКИХ ИССЛЕДОВАНИЯХ (ОБЗОР). Разработка и регистрация лекарственных средств. 2017;(2):246-250.

For citation:


Yaichkov I.I., Khokhlov A.L., Dzhurko Y.A., Shitov L.N., Trubnikov A.A. METHODS OF STABILIZATION OF DRUG SUBSTANCES AND THEIR METABOLITES IN BIOLOGICAL FLUIDS DURING BIOANALYTICAL STUDY (REVIEW). Drug development & registration. 2017;(2):246-250. (In Russ.)

Просмотров: 45


Creative Commons License
Контент доступен под лицензией Creative Commons Attribution 4.0 License.


ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)