Published February 27, 2021 | Version v1
Journal article Open

The use of liquid chromatography method for quantitative determination of active substances in Enalapril-H tablets

Creators

  • 1. National University of Pharmacy
  • 2. JSC "Farmak"
  • 3. Lithuanian University of Health Sciences
  • 4. Kharkiv Medical Academy of Postgraduate Education

Description

The aim. Combination therapy is used to treat hypertension. Strengthening the action of the ACE inhibitor enalapril is carried out in combination with the thiazide diuretic hydrochlorothiazide. On the pharmaceutical market, such combined preparations are presented by different manufacturers in various concentrations of the active ingredients of enalapril maleate and hydrochlorothiazide. Development of methods for the quantitative determination of active substances in combined drugs by liquid chromatography is topical.

Materials and methods. Shimadzu Nexera X2 LC-30AD liquid chromatograph equipped with DAD SPD-M20A diode array detector, SIL-30AC autosampler and CTO-20AC column thermostat; analytical balance - UniBloc AUW120D; pH meter - Knick type 911pH; chromatographic column ACE C18, size 250 mm × 4.6 mm, packed with octadecylsilyl silica gel for chromatography with a particle size of 5 μm.

Results. Based on the results of the work, a method for the quantitative determination of enalapril and hydrochlorothiazide in the presence of HPLC was proposed. The obtained validation characteristics indicate that the method for the quantitative determination of hydrochlorothiazide in Enalapril-H tablets corresponds to the following parameters: correctness, precision, linearity ( =0.70 ≤ max =1.60, d=0.22 ≤ maxd = 0.51, a=0.71  max a=2.60, r = 0.9997  min r=0.9981). In the quantitative determination of enalapril maleate in combined tablets, it was found that correctness, precision, linearity are performed ( =1.21 ≤ max =1.60, d=0.24 ≤ max d=0.51, a=1.35  max a=2.60, r = 0.9991  min r= 0.9981).

Conclusions. The method of quantitative chromatographic determination of enalapril maleate and hydrochlorothiazide in an antihypertensive combination drug has been improved. The proposed parameters of the chromatographic separation of the mixture in comparison with the initial ones contribute to a decrease in the costs of monitoring, a decrease in the volume of harmful emissions and cause an extension of the life of the chromatographic column

Files

The use of liquid chromatography method for quantitative determination of active substances in Enalapril-H tablets.pdf

Files (801.2 kB)

Additional details

References

  • Unifikovanyi klinichnyi protokol pervynnoi, ekstrenoi ta vtorynnoi (spetsializovanoi) medychnoi dopomohy. Arterialna hipertenziia. (2012). Zatverdzheno Nakaz Ministerstva okhorony zdorovia. No. 384. 24.05.2012. Available at: https://www.dec.gov.ua/wp-content/uploads/2019/11/384_2012ykpmd_ag.pdf
  • Tsioufis, C., Dimitriadis, K., Mantzouranis, E., Mani, I., Tousoulis, D. (2016). Differential effects of lercanidipine/enalapril versus amlodipine/enalapril and hydrochlorothiazide/enalapril on target organ damage and sympathetic activation in non-obese essential hypertensive subjects. Current Medical Research and Opinion, 32 (2), 35–41. doi: http://doi.org/10.1080/03007995.2016.1218839
  • Van Nguyen, N. T. (2019). Combination therapy at the start of hypertension treatment: pros and cons. E-Journal of Cardiology Practice, 17 (20). Available at: https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-17/combination-therapy-at-the-start-of-hypertension-treatment-pros-and-cons
  • Kalra, S., Kalra, B., Agrawal, N. (2010). Combination therapy in hypertension: An update. Diabetology & Metabolic Syndrome, 2 (1). doi: http://doi.org/10.1186/1758-5996-2-44
  • Wedian, F., Lataifeh, A. (2013). Application of the Bivariate Calibration for Simultaneous Determinations of Hydrochlorothiazide/Enalapril Maleate and Hydrochlorothiazide/Bisoprolol Fumarate in Drug Tablets. International Journal of Chemistry, 5 (2). doi: http://doi.org/10.5539/ijc.v5n2p29
  • Borghi, C., Soldati, M., Bragagni, A., Cicero, A. F. . (2020). Safety implications of combining ACE inhibitors with thiazides for the treatment of hypertensive patients. Expert Opinion on Drug Safety, 19(12), 1577–1583. doi: http://doi.org/10.1080/14740338.2020.1836151
  • Novytska, A. V., Korost, Ya. V., Siryk, V. O. (2017). Kombinovana terapiia arterialnoi hipertenzii: vybir naikrashchoho variantu. Liky Ukrainy, 5 (211), 22–25.
  • Burnier, M., Bakris, G., Williams, B. (2019). Redefining diuretics use in hypertension. Journal of Hypertension, 37 (8), 1574–1586. doi: http://doi.org/10.1097/hjh.0000000000002088
  • ENALAPRIL-H/NL-ZDOROVYE. Kompendium. Lekarstvennye sredstva. Available at: https://compendium.com.ua/info/168310/enalapril-h-zdorov_e/
  • Derzhavnyi reiestr likarskykh zasobiv Ukrainy. Available at: http://www.drlz.com.ua/
  • The United States Pharmacopoeia, 41 – NF 36 (2018). The United States Pharmacopeial Convention. Rockville. Available at: https://opac.kku.ac.th/catalog/BibItem.aspx?BibID=b00420302
  • Koppala, S., Ranga Reddy, V., Anireddy, J. S. (2017). User-Friendly HPLC Method Development and Validation for Determination of Enalapril Maleate and Its Impurities in Enalapril Tablets. Journal of Chromatographic Science, 55 (10), 979–988. doi: http://doi.org/10.1093/chromsci/bmx060
  • Abdelrahman, M. M. (2014). Selective spectrophotometric methods for determination of ternary mixture with overlapping spectra: A comparative study. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 124, 389–396. doi: http://doi.org/10.1016/j.saa.2014.01.020
  • Leontiev, D. A., Volovyk, N. V., Bevz, O. V., Vashchenko, O. V., Gryzodub, O. I. (2018). Characterization of a reference standard for qualification of differential scanning calorimetry intended for purity determination in certification of pharmaceutical reference standards. Journal of Pharmaceutical Sciences and Research, 10 (11), 2709–2714.
  • Hammouda, M. E. A., Abu El-Enin, M. A., El-Sherbiny, D. T., El-Wasseef, D. R., El-Ashry, S. M. (2014). Simultaneous Determination of Enalapril and Hydrochlorothiazide in Pharmaceutical Preparations Using Microemulsion Liquid Chromatography. Journal of Chromatographic Science, 53 (1), 90–96. doi: http://doi.org/10.1093/chromsci/bmu024
  • Uslu, B., Özden, T. (2013). HPLC and UPLC Methods for the Simultaneous Determination of Enalapril and Hydrochlorothiazide in Pharmaceutical Dosage Forms. Chromatographia, 76 (21-22), 1487–1494. doi: http://doi.org/10.1007/s10337-013-2442-6
  • Balkanov, T., Logoyda, L., Piponski, M. (2021). Development and validation of a fast and simple HPLC method for the simulta-neous determination of bisoprolol and enalapril in dosage form. Pharmacia, 68 (1), 69–77. doi: http://doi.org/10.3897/pharmacia.68.50919
  • British Pharmacopoeia (2020). Available at: https://www.pharmacopoeia.com/
  • Komarytskyy, I. L., Khanin, V. A., Bevz, N. Y., Georgiyants, V. A. (2015). Verification of HPLC method for quantitative determination of amlodipine besylate in tablets. Russian Journal of Biopharmaceuticals, 7 (2), 17–20.
  • Derzhavna Farmakopeia Ukrainy. Vol. 1 (2015). Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 1128.
  • The European Pharmacopoeia (2018). European Directorate for the Quality of Medicines & HealthCare of the Council of Europe. Strasbourg, 6.
  • Derzhavna Farmakopeia Ukrainy (2020). Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 600.