Validation of Amoxicillin iodometric procedure in quantitative analysis of pure substance and medical preparation

Authors

DOI:

https://doi.org/10.14739/2409-2932.2022.1.251985

Keywords:

analysis, validation, amoxicillin, potassium caroate

Abstract

The aim of the work is to validate a simple and rapid iodometric procedure for the quantitative determination of amoxicillin in pure substance and medicinal preparation using potassium caroate as analytical reagent.

Materials and methods. The procedure involves the use of potassium caroate (KHSO5) as an oxidant. The assay is based on the quantitative penicillin oxidation by KHSO5 to the corresponding S-oxide. The interaction between amoxicillin and analytical reagent is stoichiometric. Indirect iodometric method is used for the quantitative determination of amoxicillin main substance. The validation procedure was performed according to the State Pharmacopeia of Ukraine.

Results. The precision, accuracy, limit of detection (LOD), and limit of quantitation (LOQ) are accepted over the concentration range of 80–120 % with a correlation coefficient of 0.999. LOD and LOQ were found to be 4.91 % and 14.73 % for amoxicillin pure substance respectively. The precision calculated as the relative standard deviation (RSD) was less than 0.8 % and accuracy (δ, relative error) was better than 0.4 %. The proposed method was validated statistically and through recovery studies. For Amoxicillin medical preparation RSD ≥1.93 % and δ ≥ 1.62 %.

Conclusions. The obtained data showed acceptable agreement with the certificate results, so the proposed procedure can be used for the assay of amoxicillin in medicinal preparation.

Author Biographies

Yu. Yu. Serdiukova, National University of Pharmacy, Kharkiv, Ukraine

PhD, Associate Professor of the Department of Inorganic and Physical Chemistry

O. V. Kolisnyk, National University of Pharmacy, Kharkiv, Ukraine

PhD, Associate Professor of the Department of Pharmaceutical Chemistry

Т. О. Tomarovska, National University of Pharmacy, Kharkiv, Ukraine

PhD, Associate Professor of the Department of Inorganic and Physical Chemistry

S. M. Poluian, National University of Pharmacy, Kharkiv, Ukraine

PhD, Associate Professor of the Department of Analytical Chemistry and Analytical Toxicology

Z. V. Shovkova, National University of Pharmacy, Kharkiv, Ukraine

PhD, Associate Professor of the Department of Analytical Chemistry and Analytical Toxicology

O. H. Pohosian, National University of Pharmacy, Kharkiv, Ukraine

PhD, Associate Professor of the Department of Analytical Chemistry and Analytical Toxicology

References

Sun, L., Jia, L., Xie, X., Xie, K., Wang, J., Liu, J., Cui, L., Zhang, G., Dai, G., & Wang, J. (2016). Quantitative analysis of amoxicillin, its major metabolites and ampicillin in eggs by liquid chromatography combined with electrospray ionization tandem mass spectrometry. Food chemistry, 192, 313-318. https://doi.org/10.1016/j.foodchem.2015.07.028

Wang, B., Pang, M., Xie, X., Zhao, M., Xie, K., Zhang, Y., Zhao, X., Wang, Y., Wang, R., Wu, H., Zhang, G., Dai, G., & Wang, J. (2017). Quantitative Analysis of Amoxicillin, Amoxicillin Major Metabolites, and Ampicillin in Chicken Tissues via Ultra-Performance Liquid Chromatography-Electrospray Ionization Tandem Mass Spectrometry. Food Analytical Methods, 10(10), 3292-3305. https://doi.org/10.1007/s12161-017-0900-8

Blazheyevskiy, M. Y., Karpova, S. P., & Kabachnyy, V. I. (2013). Quantitative determination of some penicillin by iodometric method using potassium peroxomonosulphate. Journal of Chemical and Pharmaceutical Research, 5(11), 637-643.

Pham, T. H. Y., Mai, T. T., Nguyen, H. A., Chu, T. T. H., Vu, T. T. H., & Le, Q. H. (2021). Voltammetric Determination of Amoxicillin Using a Reduced Graphite Oxide Nanosheet Electrode. Journal of Analytical Methods in Chemistry, 2021. https://doi.org/10.1155/2021/8823452

Valenga, M. G. P., Felsner, M. L., de Matos, C. F., de Castro, E. G., & Galli, A. (2020). Development and validation of voltammetric method for determination of amoxicillin in river water. Analytica Chimica Acta, 1138, 79-88. https://doi.org/10.1016/j.aca.2020.09.020

Sharma, D. K., Sood, S., & Raj, P. (2019). Spectrophotometric Determination of Amoxicillin, Ampicillin, Cefalexin and Cefadroxil in Pharmaceutical Formulations, Biological Fluids and Spiked Water Samples. Analytical Chemistry Letters, 9(3), 345-361. https://doi.org/10.1080/22297928.2019.1644194

Othman, N. S., & AL-Saffar, R. S. (2015). Spectrophotometric Determination of Amoxicillin in Pharmaceutical Preparations. International Journal of Enhanced Research in Science Technology & Engineering, 4(6), 167-173.

Chivulescu, A. I., Badea Doni, M., Cheregi, M. C., & Danet, A. F. (2011). Determination of amoxicillin, ampicillin and penicillin G using a flow injection analysis method with chemiluminescence detection. Revue Roumaine de Chimie, 56(3), 247-254.

Fuwei, W., Jinghua, Y., Ping, D., & Shenguang, G. (2010). Molecular imprinting-chemiluminescence sensor for the determination of amoxicillin. Analytical Letters, 43(6), 1033-1045. https://doi.org/10.1080/00032710903491104

European Directorate for the Quality of Medicines & Health Care (2010). European Pharmacopoeia (Vol. 1-2, 7th ed.) Strassbourg: Council of Europe.

British Pharmacopoeia (2009). London: The Stationery office.

European Pharmacopoeia (2003). (4th ed., pp. 2975-2977). Strasbourg: Council of Europe.

Demskaya, E. V., & Alekseev, V. G. (2005). Analiz lekarstvennykh form ampitsillina, amoksitsillina i tsefaleksina metodom rN-metricheskogo titrovaniya [Analysis of dosage forms of ampicillin, amoxicillin and cephalexin by pH-metric titration]. Vestnik Tverskogo gosudarstvennogo universiteta, 8(2), 177-179. [in Russian].

State Enterprise Ukrainian Scientific Pharmacopoeial Center of Medicines Quality. (2014). Derzhavna Farmakopeya Ukrayiny [The State Pharmacopoeia of Ukraine] (Vol. 1, 2nd ed.). Kharkiv: State Enterprise Ukrainian Scientific Pharmacopoeial Center of Medicines Quality. [in Ukrainian].

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Published

2022-03-15

How to Cite

1.
Serdiukova YY, Kolisnyk OV, Tomarovska ТО, Poluian SM, Shovkova ZV, Pohosian OH. Validation of Amoxicillin iodometric procedure in quantitative analysis of pure substance and medical preparation. Current issues in pharmacy and medicine: science and practice [Internet]. 2022Mar.15 [cited 2024Jul.21];15(1):19-24. Available from: http://pharmed.zsmu.edu.ua/article/view/251985

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Original research