DEVELOPMENT AND VALIDATION OF MOXIFLOXACIN DETERMINATION IN HUMAN PLASMA BY HPLC-UV METHOD
Abstract
A new method for determination of moxifloxacin in human plasma using HPLC with UV-detection is described. The sample preparation was made by protein precipitation by 50% trifluoracetic acid solution. The method was validated in terms of selectivity, calibration curve, accuracy, precision, lower limit of quantification, carry-over and stability. The analytical range was 100-5000 ng/mL. Limit of determination was 31 ng/mL. Method could be applied to moxifloxacin determination in plasma for PK and BE studies.
About the Authors
T. N. Komarov
Center of Pharmaceutical Analytics Ltd.
Russian Federation
Russian Federation
Yu. V. Medvedev
Center of Pharmaceutical Analytics Ltd.;
I.M. Sechenov First Moscow State Medical University
Russian Federation
Russian Federation
I. E. Shohin
Center of Pharmaceutical Analytics Ltd.
Russian Federation
Russian Federation
Yu. E. Boldina
Center of Pharmaceutical Analytics Ltd.
Russian Federation
Russian Federation
A. A. Lvova
Center of Pharmaceutical Analytics Ltd.
Russian Federation
Russian Federation
E. S. Melnikov
Center of Pharmaceutical Analytics Ltd.
Russian Federation
Russian Federation
E. N. Fisher
Center of Pharmaceutical Analytics Ltd.;
I.M. Sechenov First Moscow State Medical University
Russian Federation
Russian Federation
R. V. Ivanov
R&D PHARMA Ltd.
Russian Federation
Russian Federation
R. J. Maksvitis
R&D PHARMA Ltd.
Russian Federation
Russian Federation
References
1. Регистр лекарственных средств России: электронная версия. URL: http://www.rlsnet.ru/mnn_index_ id_2812.htm (дата обращения 28.03.2016).
2. A.K. Hemanth Kumar, G. Ramachandran. Simple and rapid liquid chromatography method for determination of moxifloxacin in plasma // Journal of Chromatography B 2009. V. 877. Р. 1205-1208.
3. S.T. Ulu. High-performance liquid chromatography assay for moxifloxacin: Pharmacokinetics in human plasma // Journal of Pharmaceutical and Biomedical Analysis. 2007. V. 43. Is. 1. Р. 320-324.
4. Y.H. Xua, D. Lib, X.Y. Liua, Y.Z. Lia, J. Luc. High performance liquid chromatography assay with ultraviolet detection for moxifloxacin: Validation and application to a pharmacokinetic study in Chinese volunteers // Journal of Chromatography B. 2010. V. 878. Р. 3437-3441.
5. Руководство по экспертизе лекарственных средств / Под. ред. проф. А.Н. Миронова. Т. I. - М.: Гриф и К, 2013. 328 с.
6. Guidance for Industry: Bioanalytical method validation. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evolution and Research (CDER). - Washington, DC: U.S. Government Printing Office, 2013.
7. Guideline on bioanalytical method validation (European medicines agency). Committee for Medicinal Products of Human Use (CHMP). - London. 2011.
Review
For citations:
Komarov T.N., Medvedev Yu.V., Shohin I.E., Boldina Yu.E., Lvova A.A., Melnikov E.S., Fisher E.N., Ivanov R.V., Maksvitis R.J. DEVELOPMENT AND VALIDATION OF MOXIFLOXACIN DETERMINATION IN HUMAN PLASMA BY HPLC-UV METHOD. Drug development & registration. 2016;(3):174-179. (In Russ.)
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