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

Authors

DOI:

https://doi.org/10.15587/2519-4852.2021.225569

Keywords:

liquid chromatography, enalapril maleate, hydrochlorothiazide, analytical method validation, quantitative determination

Abstract

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

Author Biographies

Nataliia Bevz, National University of Pharmacy

PhD, Associate Professor

Department of Pharmaceutical Chemistry

Artem Myhal, JSC "Farmak"

PhD, Engineer

API Synthesis laboratory

Department of Research and Development

Liudas Ivanauskas, Lithuanian University of Health Sciences

Doctor of Biomedical Sciences, Professor, Head of Department

Department of Analytical and Toxicological Chemistry

Olga Gorokhova, National University of Pharmacy

PhD, Associate Professor

Department of Pharmaceutical Chemistry

Vasyl Grynenko, National University of Pharmacy

PhD, Associate Professor

Department of Pharmaceutical Chemistry

Iryna Zhuravel, Kharkiv Medical Academy of Postgraduate Education

Doctor of Chemical Sciences, Professor

Department of Clinical Biochemistry, Forensic Toxicology and Pharmacy

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Published

2021-02-27

How to Cite

Bevz, N., Myhal, A., Ivanauskas, L., Gorokhova, O., Grynenko, V., & Zhuravel, I. (2021). The use of liquid chromatography method for quantitative determination of active substances in Enalapril-H tablets . ScienceRise: Pharmaceutical Science, (1 (29), 39–50. https://doi.org/10.15587/2519-4852.2021.225569

Issue

No. 1 (29) (2021)

Section

Pharmaceutical Science

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Copyright (c) 2021 Наталия Юрьевна Бевз , Артем Владимирович Мигаль , Liudas Ivanauskas, Ольга Викторовна Горохова , Василий Васильевич Гриненко , Ирина Александровна Журавель

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