Analytical approaches to examine the pharmacokinetics anticancer drugs by methods gas and liquid chromatography
Abstract
The present study is devoted to the comparative analysis of previously developed and published
methods of quantitative determination of anticancer drugs capecitabine (with the the active metabolite 5-
fluorouracil), temozolomide, imatinib, anastrozole in human blood plasma. Previously there have been
developed and published methods for determining capecitabine, 5-fluorouracil, temozolomide and imatinib
by LC-MS and LC with UV- detector and anastrozole by GC-MS and LC-MS. The developed techniques
were validated in terms of selectivity, linearity, accuracy, precision, stability samples, matrix effect, limit of
quantification, the transfer of samples. To select the most useful methods for further studies of
pharmacokinetics study drugs provides a comparative statistical analysis of previously developed
bioanalytical methods with the use of F-test calculation. Based on these data, it is the choice of the optimal
use of various methods of liquid or gas chromatography for the analysis of the studied drugs in human
plasma for further research.
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References
Cancer Chemotherapy Handbook, 2003, 6th
Edition, pp.47
2.Rasporyazhenie pravitel'stva RF RF №2427
ot 19.12.2013 g "Ob utverzhdenii spiska
zhiznenno neobkhodimykh i vazhneishikh
lekarstvennykh preparatov na 2014 g".
3.Perechen' strategicheski znachimykh
lekarstvennykh sredstv, proizvodstvo kotorykh
dolzhno byt' obespecheno na territorii
Rossiiskoi Federatsii. Utverzhden
Rasporyazheniem Pravitel'stva RF №1141-r ot
6 iyulya 2010 g.
4.Prikaz «Ob utverzhdenii strategii razvitiya
farmatsevticheskoi promyshlennosti na period
do 2020 goda». Ministerstvo promyshlennosti i
torgovli Rossiiskoi Federatsii., M., 2009 g.
5.Komarov T. Nekotorye voprosy
farmakokineticheskikh issledovanii
protivoopukholevykh preparatov, Razrabotka i
registratsiya lekarstvennykh sredstv, 2014, No
2(7)
6.Komarov T., Medvedev Yu., Ramenskaya
G., Shokhin I., Midruev E., Razrabotka i
validatsiya metodiki opredeleniya
protivoopukholevogo preparata kapetsitabina i
ego aktivnogo metabolita 5-ftoruratsila v
plazme krovi s tsel'yu provedeniya
farmakokineticheskikh issledovanii,
Biofarmatsevticheskii zhurnal, 2014, T. 6, No
5, pp. 62-67.
7.Komarov T., Medvedev Yu., Shokhin I.,
Midruev E., Yarushok T., Razrabotka i
validatsiya metodiki opredeleniya
protivopukholevogo preparata temozolomida v
plazme krovi, Razrabotka i registratsiya
lekarstvennykh sredstv, 2014, No2(7), pp.132-
135
8.Komarov T., Ramenskaya G., Mel'nikov E.
Izucheniya vozmozhnostei primeneniya
9.metodov gazovoi khromatografii i
vysokoeffektivnoi zhidkostnoi khromatografii s
mass-selektivnym detektirovaniem dlya
opredeleniya nekotorykh protivoopukholevykh
lekarstvennykh sredstv v plazme krovi, Sbornik
materialov nauchnoi konferentsii,
posvyashchennoi 35-letiyu YuKGFA.
Kazakhstan, Shymkent, oktyabr' 2014.
10. Komarov T., Ramenskaya G., Shokhin I.,
Medvedev Yu., Midruev E., Opredelenie
protivoopukholevogo preparata imatiniba v
plazme krovi cheloveka s pomoshch'yu
svervysokoeffektivnoi zhidkostnoi
khromatografii, Estestvennye i tekhnicheskie
nauki, 2014, [in edition].
11. Komarov T., Ramenskaya G., Shokhin I.,
Medvedev Yu., Midruev E., Boldina Yu.,
L'vova A. Opredelenie nekotorykh
protivoopukholevykh preparatov iz spiska
ZhNVLP v plazme krovi s pomoshch'yu
sverkhvysokoeffevtivnoi zhidkostnoi
khromatografii s mass-selektivnym
detektirovaniem, Sorbtsionnye i
khromatograficheskie protsessy, 2014, [in
edition].
12. Guidance on the Investigation of
Bioequivalence. European Medicines Agency
(EMA). Committee for Medicinal Products of
Human Use (CHMP), 2010.
13. Rukovodstvo po ekspertize
lekarstvennykh sredstv pod red. prof. A.N.
Mironova, Tom I., M. Grif i K, 2013.
14. Guidance for Industry, Investigators, and
Reviewers: Exploratory IND Studies U.S.
Department of Health and Human Services,
Food and Drug Administration, Center for Drug
Evolution and Research (CDER). U.S.
Government Printing Office: Washington, DC, 2006.
