Articles
Yegorova А.V., Scrypynets Yu.V., Fedosenko G.O., Maltsev G.V., Kashutskiy S.M. Practical application of high-performance liquid chromatography and high-performance thin-layer chromatography in pharmaceutical analysis
UDC: 543.544:615.07M
DOI: 10.15407/zht2021.67.046
Yegorova A.V., Scrypynets Yu.V., Fedosenko G.O., Maltsev G.V., Kashutskiy S.M.
Practical application of high-performance liquid chromatography and high-performance thin-layer chromatography in pharmaceutical analysis
Currently, chromatographic methods are widely used to control the quality of products in the pharmaceutical and food industries. This article is devoted to the systematization of the results of scientific research of the authors on the development, validation and application of a number of chromatographic methods in the creation of generic drugs, as well as in the analysis of medicinal plant materials. The developed methods are validated according to the following parameters: specificity, linearity, accuracy and limit of detection. The specificity of the methods is based on the ability to evaluate the analyte in the presence of other components and is confirmed by using external standards. The accuracy was assessed by the results of the analysis of different weights or by the "added-found" method. For the developed methods, parameters of the suitability of chromatographic systems were established (peak symmetry factor, number of theoretical plates, relative standard deviation of retention time and peak area). HPLC methods have been developed for the determination of active substances in combined preparations, for the study of dissolution profiles, and the determination of residual amounts of drugs on the surfaces of pharmaceutical equipment. The HPTLC methods for determining the residual amounts of plant materials – dry extract of ginkgo biloba leaves (by quercetin content) and curcumin in “Gallina Blanca” bouillon cubes are proposed. The proposed methods are characterized by satisfactory metrological characteristics and ease of analysis.
Key words: high-performance liquid chromatography, high-performance thin-layer chromatography, validation, active pharmaceutical ingredient.
REFERENCES
1. Analiticheskaya khimiya v sozdanii, standartizatsii i kontrole kachestva lekarstvennyih sredstv: v 3-h tomah. Pod red. chlena-korr. NAN Ukrayiny V.P. Georgievskogo. Kharkov, izd-vo «NTMT». 2011. T. 2. 474 s.
2. Georgievskiy V.P., Georgievskiy G.V., Zinchenko A.A., Kulikov A.Yu., Nazarova E.S., Kolisnyik A.V. Hromatograficheskie metodyi v analiticheskom obespechenii sozdaniya i kontrolya kachestva lekarstvennykh sredstv v Ukraine. Pod red. chlen-korr. NAN Ukrayiny V.P. Georgievskogo. Kharkov: «NTMT». 2016. 288 s.
3. Golubitskiy G.B., Budko E.V., Ivanov V.M., Basova E.M. Kolichestvennyiy analiz tabletok «Pentalgin» metodami gradientnoy i izokraticheskoy vyisokoeffektivnoy zhidkostnoy hromatografii. Zhurn. analit. himii. 2006. 61 (4). S. 383-387.
4. Grizodub A.I., Leont'ev D.A., Dotsenko T.N., Zagoriy V.A. Standartizovnnaya protsedura validatsii metodik kontrolya soderzhaniya primesey v gotovykh lekarstvennykh sredstvah metodom zhidkostnoy khromtografii. Farmakom. 2005. 2 – 3. S. 78-94.
5. Pogulyay T.V., Vityukova E.O., Egorova A.V., Giher Z.A., Antonovich V.P. Kolichestvennyiy analiz preparata «Teofedrin» metodom vyisokoeffektivnoy zhidkostnoy hromatografii. Farmakom. 2008. 1. S. 73-80.
6. Pogulyay T.V., Vityukova E.O., Egorova A.V., Giher Z.A., Antonovich V.P. AnalIz preparatu «Trifedrin» metodom vyisokoefektivnoYi rIdinnoYi hromatografIYi. Farmatsevtichniy zhurnal. 2008. 4. S. 81-87.
7. Voytyuk O.D., Egorova A.V., Skripinets Yu.V., Kashutskiy S.M., Umetska I.V. VERH-viznachennya zalishkovih kIlkostey fenoksietanolu – komponentu miyno-dezInfektsIynogo zasobu «IntsidIn Pro». Farmatsevtichniy zhurnal. 2020. 75 (1). S. 72-79. DOI: 10.32352/0367-3057.1.20.08
8. Voytyuk O.D., Egorova A.V., Skripinets Yu.V., Kashutskiy S.M., Klyuchnik O.G., Umetska I.V. VERH-viznachennya aktivnih komponentIv u dIEtichnIy dobavtsI «L-KARNITIN SMART». Farmatsevtichniy zhurnal. 2019. 1. S. 86 – 96. DOI: 10.32352/0367-3057.1.19.08
9. Egorova A.V., Maltsev G.V., Skripinets Yu.V., Voytyuk O.D., Kashutskiy S.N., Umetskaya I.V., Antonovich V.P. VEZhH-metodika kolichestvennogo opredeleniya metamizola natriya s uchetom ego razlozheniya v vodnyih rastvorah pri izuchenii profiley rastvoreniya. Zhurn. analit. khimii. 2021. 76 (4). S. 324-330. DOI: 10.31857/S0044450221020055
10. Egorova A.V., Fedosenko A.A., Vityukova E.O., Kashutskiy S.N., Maltsev G.V. Validatsiya metodiki VEZhH opredeleniya ostatochnyih kolichestv klofelina gidrohlorida s poverhnostey farmoborudovaniya. Visnik Odeskogo natsion. un-tu. Khimiya. 2014. 19. 3(51). S. 40-51. http://nbuv.gov.ua/UJRN/Vonu_chem_2014_19_3_6
11. Fedosenko G.O., Skripinets Yu.V., Leonenko I.I., Egorova A.V., Kashutskiy S.M., Antonovich V.P. Viznachennya zalishkovih kIlkostey glyukozi na poverhnyah farmobladnannya metodami polyarimetrIYi ta VERH. Farmatsevtichniy zhurnal. 2015. 5. S. 83-89.
12. Egorova A.V., Fedosenko A.A., Skripinets Yu.V., Leonenko I.I., Maltsev G.V., Antonovich V.P. Opredelenie ostatochnyih kolichestv rozuvastatina kaltsiya na poverhnostyah farmatsevticheskogo oborudovaniya metodami VEZhH i lyuminestsentsii. Zhurn. anal. khimii. 2016. 71(1). S. 129-135. DOI: 10.7868/S0044450215110043
13. Egorova A.V., Fedosenko A.A., Skripinets Yu.V., Leonenko I.I., Maltsev G.V., Antonovich V.P. Opredelenie ostatochnyih kolichestv rivastigmina gidrotartrata na poverhnostyah farmoborudovaniya metodami VEZhH i lyuminestsentsii. Visnik Odeskogo natsion. un-tu. Khimiya. 2017. 22. 1(61). S. 67-78. DOI: http://dx.doi.org/10.18524/2304-0947.2017.1(61).94713
14. Fedosenko G.O., Yegorova A.V., Scrypynets Yu.V., Leonenko I.I., Vitukova E.O. Determination of fenspiride hydrochloride residues on pharmaceutical manufacturing equipment surfaces by HPLC method. French-Ukrainian Journal of Chemistry. 2018. 6 (1). S. 7-15.
15. Egorova A.V., Fedosenko A.A., Maltsev G.V., Antonovich V.P. Validatsiya metodik kontrolya kachestva ochistki farmatsevticheskogo oborudovaniya. Analitika i kontrol'. 2015. 19 (4). S. 387-395. DOI: 10.15826/analitika.2015.19.4.002
16. Egorova A.V., Fedosenko A.A., Maltsev G.V., Kaschutskiy S.N., Antonovich V.P. VEZhH opredelenie L-valina, L-leytsina i L-izoleytsina s ispolzovaniem predkolonochnoy derivatizatsii di-tret-butildikarbonatom. Methods and objects of chem. anal. 2017. 12 (2). P. 91-98. DOI: 10.17721/moca.2017.91-98
17. Egorova A.V., Fedosenko G.O., Maltsev G.V., Kashutskiy S.M., Antonovich V.P. Pat. 120119 Ukrayina MPK G01N30/00, G01N30/02, G01N33/15, Sposib kilkisnogo viznachennya amInokislot; zayavnik ta patentovlasnik Odesa, FHI Im. O.V. Bogatskogo NAN Ukrayiny, – N U 2017 03754; zayavl. 18.04.2017; opubl. 25.10.2017, Byul. N 20.
18. Egorova A.V., Fedosenko A.A., Maltsev G.V., Antonovich V.P. Validatsiya metodiki opredeleniya ostatochnyih kolichestv tsinhokaina gidrohlorida metodom zhidkostnoy hromato-mass-spektrometrii. Upravlinnya yakistyu v farmatsiyi: zbirnik naukovih robit H naukovo-praktichnoyi konferentsiyi. Kharkiv. 2016. S. 170-173.
19. Baghel U.S., Nagar A.S., Pannu M. et al. HPLC and HPTLC methods for simultaneous estimation of quercetin and curcumin in polyherbal formulation. Indian J. Pharm. Sci. 2017. 79. P. 197-203. https://doi.org/10.4172/pharmaceutical-sciences.1000217.
20. Egorova A.V., Fedosenko A.A., Maltsev G.V., Kashutskiy S.N., Antonovich V.P. Opredelenie ostatochnyih kolichestv suhogo ekstrakta listev ginkgo biloba na poverhnostyah farmatsevticheskogo oborudovaniya metodom vyisokoeffektivnoy tonkosloynoy hromatografiih. Methods and objects of chem. anal. 2015. 10 (4). P. 183-188. https://doi.org/10.17721/moca.2015.183-188
21. Egorova A.V., Fedosenko G.O., Maltsev G.V., Kashutskiy S.M., Antonovich V.P. Pat. 108176 Ukrayina MPK G01N33/15, G01N33/50 SposIb kIlkIsnogo viznachennya kvertsetinu; zayavnik ta patentovlasnik Odesa, FHI Im. O.V. Bogatskogo NAN Ukrayiny, – N u 2015 12228; zayavl. 10.12.2015; opubl. 11.07.2016, Byul. N 13.
22. Egorova A.V., Loskutova Yu.O., Voytyuk O.D., Maltsev G.V., Malinka E.V., Skripinets Yu.V. Opredelenie kurkumina v bulonnyih kubikah metodom vyisokoeffektivnoy tonkosloynoy hromatografii. Zurnal Hromatograficnogo tovaristva. 2020. 20. S. 4-13. DOI: 10.15407/zht2020.66.004.