Quantitative determination of active substances of combined infusion solution by HPLC method

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Introduction. The quantitative determination of substances and finished pharmaceutical products is a pivotal criterion in the assessment of their quality during serial production and control within the pharmaceutical market. This indicator ensures the accurate dosage of the active substance in the product, thereby ensuring the anticipated therapeutic effect. Consequently, the development of a uniform method for determining the quantitative content of active pharmaceutical ingredients in substances or dosage forms constitutes a significant undertaking within the domain of pharmaceutical analysis.

Objective. This study aimed to develop and validate an HPLC method for the quantitative determination of active substances in a combined infusion solution.

Material and methods. The objects of the analysis were an infusion solution containing L-arginine hydrochloride and L-glutamic acid, produced by Temur Med Farm LLC.

The content of the active substances in the infusion solution was determined by high-performance liquid chromatography (HPLC) in gradient mode with ultraviolet (UV) detection.

Results. A method for the quantitative determination of L-arginine and L-glutamic acid in an infusion solution is proposed with a relative error not exceeding ±0.83%. The developed method has been validated and meets the established criteria for linearity, accuracy, and precision.

Conclusion. The validation results confirm that the developed high-performance liquid chromatography method for the quantitative determination of L-arginine and L-glutamic acid in this drug meets all the requirements and can be used to control its quality.

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作者简介

Shakhnozakhon Agloxodjaeva

Tashkent Pharmaceutical Institute

编辑信件的主要联系方式.
Email: agloxodjayevashaxnoza@gmail.com
ORCID iD: 0009-0000-2366-4756

2nd year PhD-student in the direction 15.00.02 “Pharmaceutical chemistry and pharmacognosy”

乌兹别克斯坦, Aybek str., 45, Tashkent, 100015

Azizakhon Tashpulatova

Tashkent Pharmaceutical Institute

Email: aiza2505@mail.ru
ORCID iD: 0009-0000-5428-9039

Doctor of Pharmaceutical Sciences, Associate Professor, Professor of the Department of Pharmaceutical Chemistry

乌兹别克斯坦, Aybek str., 45, Tashkent, 100015

参考

  1. Абдуназаров А.И., Ташпулатова А.Д. Определение показателей качества комбинированного ноотропно го препарата. Фармация, 2024; 73 (2): 40–5. [Abdunazarov A.I., Tashpulatova A.D. Determination of quality indicators of a combined nootropic drug. Farmatsiya, 2024; 73 (2): 40–5. https://doi.org/10.29296/25419218-2024-02-06 (in Russian)].
  2. Шпрах З.С., Игнатьева Е.В., Ярцева И. В. Разработка и валидация методики количественного определения аранозы в лекарственной форме. Российский Биотерапевтический Журнал. 2018; 2 (17): 57–62. [Shprakh Z.S., Ignatieva E.V., Yartseva I.V. Development and validation of a method for the quantitative determination of aranose in a dosage form. Russian J. of Biotherapy. 2018; 2 (17): 57–62 (in Russian)].
  3. ICH Harmonized Tripartite Guideline. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Q6A). [Electronic resource]. Access mode: http://www.ich. org/products/guidelines/quality/article/ quality-guidelines. html.
  4. Хацаюк А.С., Павлова О.Е., Эхова М.Э. Роль и значение высокоэффективной жидкостной хроматографии в практике высокотехнологичных лабораторных исследований. Здоровье. Медицинская экология. Наука. 2016; 3 (66): 215–9. [Hatsayuk A.S., Pavlova O.E., Echova M.E. Role and importance of high performance liquid chromatography in the practice of high-tech laboratory. Health. Medical ecology. Science. 2016; 3 (66): 215–9. DOI: 10.18411 / hmes.d-2016-146 (in Russian)].
  5. Косман В.М., Карлина М.В., Пожарицкая О.Н. Влияние условий пробоподготовки и режима хроматографирования на уровень фонового сигнала при ВЭЖХ-УФ-анализе плазмы крови. Ведомости Научного центра экспертизы средств медицинского применения. 2020; 10 (2): 121–8. [Kosman V.M., Karlina M.V., Pozharitskaya O.N. Influence of sample preparation conditions and chromatography mode on the background signal level in HPLC-UV analysis of blood plasma. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya. 2020; 10 (2): 121–8. https://doi.org/10.30895/1991-2919-2020-10-2-121-128 (in Russian)].
  6. Khusainova R.A., Abdullaeva N.K., Yunuskhodzhieva N.E. Quantitive determination and validation of cobafen (lyophilizate lomg for preparation of solution for injection) European J. of Molecular & Clinical Medicine. 2020; 07 (03): 3375–83.
  7. Abdunazarov A.I., Nishanbaev S.Z., Tashpulatova A.D., Application of TLC in quality control of Glycetam. «Actual problems of the chemistry of natural compounds» scientific conference of young scientists. 2022; 119.
  8. Валидация аналитических методик. Неопределенность в аналитических измерениях: руководства для лабораторий. Под ред. Г.Р. Кадиса. Пер. с англ. СПб.: ЦОП “Профессия”, 2016; 312. [Validation of analytical methods. Quantifying uncertainty in analytical measurements: Guide for laboratories. G.R. Nezhikhovsky, R.L. Kadis (eds.). St. Petersburg: Professiya, 2016; 312 [in Russian]
  9. Барановская В.Б., Медведевских М.Ю. Валидация методик химического анализа:международные требования. Заводская лаборатория. Диагностика материалов. 2018; 84 (12): 25–31. [Baranovskaya V.B., Medvedevskikh M.Yu. Validation of chemical analysis methods: international requirements. Industrial Laboratory. Diagnostics of Materials. 2018; 84 (12): 25–31 (in Russian)].
  10. Rao T.N. Validation of Analytical Methods. InTech. 2018. doi: 10.5772/intechopen.72087

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2. Fig. 1. Chromatogram of the investigated solution

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3. Fig. 2. Chromatogram of a solution of a working standard sample of L-arginine and L-glutamic acid

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