ANALYSIS OF APPROACHES TO THE DEVELOPMENT AND VALIDATION OF THE METHODS OF ANALYSIS OF MELDONIUM IN DRUGS AND BIOLOGICAL LIQUIDS
DOI:
https://doi.org/10.11603/mcch.2410-681X.2019.v.i4.10856Keywords:
meldonium, spectrophotometric method, high-performance liquid chromatography, quantitative analysis, method development, validationAbstract
Introduction. Analytical methods development and validation play important roles in the discovery, development and manufacture of pharmaceuticals. Method development is the process of proving that an analytical method is acceptable for use to measure the concentration of an API in a specific compounded dosage form which allow simplified procedures to be employed to verify that an analysis procedure, accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation. The analytical method validation is essential for analytical method development and tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantization limit, and robustness. In summary, analytical method development and validation allows to confirm that an accurate and reliable potency measurement of a pharmaceutical preparation can be performed. Search criteria was method development of meldonium. Literature survey has been done in range of years 1990–2019 to make the review updated and comprehensive and to show the new approaches to the development of the methods of analysis of meldonium. The sources were world recognized journals and key words used as filter were meldonium, spectrophotometric method, high-performance liquid chromatography, quantitative analysis, method development, validation.
The aim of the study – to analyze the approaches of the development and validation of the methods of analysis of meldonium in drugs and biological liquids.
Conclusion. In light of the benefits discussed in this review, we can conclude that analysts are constantly working on developing new methods of analysis of meldonium in drugs and biological liquids and on their optimization in order to save time and consumables, which also ensures the efficiency of the developed methodology. Literature survey revealed that a number of methods have been reported for estimation of meldonium individually. However, there is no analytical methods reported for the simultaneous analysis of these drugs in a combined dosage formulation.
References
Dambrova, M., Liepinsh, E., & Kalvinsh, I. (2002). Mildronate: Cardioprotective action through carnitine-lowering effect. Trends in Cardiovascular Medicine, 12, 275-279. doi: 10.1016/S1050-1738(02)00175-5
Davies, N.M., Takemoto, J.K., Brocks, D.R., & Yáñez, J.A. (2010). Multiple peaking phenomena in pharmacokinetic disposition. Clinical Pharmacokinetics, 49, 351-377. doi: 10.2165/11319320-000000000-00000
EMEA/CHMP. Guideline on Validation of Bioanalytical Methods (Draft). EMEA/CHMP/EWP/192217/ 2009. European Medicines Agency/Committee for Medicinal Products for Human Use, 2009. Retrieved from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/12/WC500018062.pdf (accessed 19 November 2009).
FDA/CDER. Guidance for Industry. Bioanalytical Method Validation. Food and Drug Administration/Center for Drug Evaluation and Research, 2001. Retrieved from: http://www.fda.gov/cder/guidance/4252fnl. (accessed 28 June 2010).
Gorbas, I.M., Barna, O.M., Sakalosh, V.U., & Bakumenko, M.A. (2010). Evaluation of prevalence and control of risk factors for cardiovascular disease among the population and doctors (Ukrainian). Drugs of Ukraine Plus, 1, 4-9.
Hmelnickis, J., Pugovičs, O., Kažoka, H., Viksna, A., Susinskis, I., & Kokums, K. (2008). Application of hydrophilic interaction chromatography for simultaneous separation of six impurities of mildronate substance. Journal of Pharmaceutical and Biomedical Analysis, 48, 649-656. doi: 10.1016/j.jpba.2008.06.011
Li, K., Li, W., & Huang, Y. (2007). Determination of free L-carnitine in human seminal plasma by high performance liquid chromatography with precolumn ultraviolet derivatization and its clinical application in male infertility. Clinica Chimica Acta, 378, 159-163. doi: 10.1016/ j.cca.2006.11.008
Li, L., Pabbisetty, D., Carvalho, P., Avery, M., Williamson, J.S., & Avery, B.A. (2008). Ultra- performance liquid chromatography–tandem mass spectrometric method for the determination of Artemisinin in rat serum and its application in pharmacokinetics. Journal of Chromatography B, 867, 131-137. doi: 10.1016/j.jchromb.2008.01.057
Lv, Y.F., Hu, X., & Bi, K.S. (2007). Determination of mildronate in human plasma and urine by liquid chromatography–tandem mass spectrometry. Journal of Chromatography B, 852, 35-39. doi: 10.1016/j.jchromb. 2006.12.031
Peng, Y., Yang, J., Wang, Z., Wang, J., Liu, Y., Luo, Z., & Wen, A. (2010). Determination of mildronate by LC-MS/MS and its application to a pharmacokinetic study in healthy Chinese volunteers. Journal of Chromatography B, 878, 551-556. doi: 10.1016/j.jchromb. 2009.12.030
Sjakstea, N., & Kalvinsh, I. (2006). Mildronate: an antiischemic drug with multiple indications. Pharmacologyonline, 1, 1-18. Retrieved from: http:// www.unisa.it/download/1966_145_754131398_1_Sjakste.pdf.
The State Pharmacopoeia of Russian Federation, 12th edn, part 1. Office of the Scientific Center of Expertise of Medical Products, Russian Federation, 2008.
Zupanets, I.A., Bezuglaja, N.P., & Podpruzhnikov, Y.V. (2009). The bioequivalence studying of drugs Vazonat and Mildronat: basis of evidence medicine and pharmacy (Ukrainian). Drugs of Ukraine, 5, 72-75. Retrieved from: http://www.health-medix.com/articles/liki_ukr/2009-08-01/LU_Zupanets.indd.pdf (accessed 01 August 2009).
Zupanets, I.A., Pidpruzhnykov, Y.V., Golovenko, M.J., Bezugla, N.P., & Borisjuk, I.Y. (2010). The study of trimethylhydrazinium propionate pharmacokinetic. Clininal Phamacy, 14, 18-23. Retrieved from: http://www.nbuv.gov.ua/portal/chem_biol/klph/2010_1/18-23. pdf (accessed 01 April 2010).
