YOUDEN’S TEST OF THE CHROMATOGRAPHIC DETERMINATION OF ATENOLOL IN PHARMACEUTICALS

Authors

  • K. Ye. Peleshok I. HORBACHEVSKY TERNOPIL NATIONAL MEDICAL UNIVERSITY
  • D. B. Koval I. HORBACHEVSKY TERNOPIL NATIONAL MEDICAL UNIVERSITY

DOI:

https://doi.org/10.11603/mcch.2410-681X.2020.v.i2.11361

Keywords:

atenolol, high-performance liquid chromatography, robustness, quantitative analysis, Youden’s test

Abstract

Introduction. Robustness tests were originally introduced to avoid problems in interlaboratory studies and to identify the potentially responsible factors. Performing a robustness test late in the validation procedure involves the risk that when a method is found not to be robust, it should be redeveloped and optimised. At this stage much effort and money have already been spent in the optimisation and validation, and therefore one wants to avoid this.

The aim of the study – to evaluate the rubustness of HPLC determination of atenolol in tablets using Youden’s test.

Research Methods. An efficient method to assess the robustness of analytical methods is by Youden’s test, by means of an experiment design which involves seven analytical parameters combined in eight tests. In the recent studies, we assessed the robustness of a chromatographic method to quantify enalapril in tablets using Youden’s test.

Results and Discussion. By using the Youden’s test criteria, HPLC method showed to be greatly robust con­cer­ning atenolol content, at the introduction of variation in seven analytic parameters. The lowest variation in atenolol content was 0.96 %, when was used column Zorbax C8 (4.6 mm i.d. ×150 mm, 5 μm). For the first time, a holistic approach involving simultaneous innovations in particle technology and instrument design was endeavored to meet and tackle the issues of the analytical laboratory. This was done in order to make analytical scientists more successful and businesses more profitable and productive.

Conclusion. Youden’s test proved to be an efficient and helpful tool for the robustness evaluation for assay of atenolol by HPLC. Youden’s test can be applied successfully for the robustness evaluation in validation process of analytical methods.

References

(2005). ICH Q2 (R1), Validation of analytical proce­dures, Text and methodology. International Conference on Harmonization. Geneva.

(2020). European Pharmacopoeia. European Pharmacopoeia. 10 edn. Retrieved from: https://www.edqm.eu/en/european_pharmacopoeia_10th_edition

(2015). The State Pharmacopeia of Ukraine in 3 vol. State Enterprise “Ukrainian Scientific Expert Phar­macopoeial Center of the Quality of Medicines” 2nd iss. Kharkiv: State Enterprise “Ukrainian Scientific and Experimental Pharmacopoeial Center for the Quality of Medicinal Products”.

Piponski, M., Peleshok, K., Logoyda, L., Krav­chuk, L., Piatnochka, V., & Zakharchuk, U. (2020). Efficient validated HPLC/UV method for determination of Valsartan and Atenolol in dosage form and in vitro dissolution studies. Biointerface Research in Applied Chemistry, 10 (6), 6669-6675.

Youden, E.H. (1975). Steiner; Statistical Manual of the Association of Official Analytical Chemists. The Association of Official Analytical Chemists ed. Arlington.

Costa da Cesar, I., & Pianetti, G.A. (2009). Robustness evaluation of the chromatographic method for the quantitation of lumefantrine using Youden’s test. Brazillian Journal of Pharmaceutical Sciences, 45, 235-240. DOI: https://doi.org/10.1590/S1984-82502009000200007

Karageorgou, E., & Samanidou, V. (2014). Youden test application in robustness assays during method validation. Journal of Chromatography A, 1353, 131-139. DOI: https://doi.org/10.1016/j.chroma.2014.01.050

Published

2020-08-25

How to Cite

Peleshok, K. Y., & Koval, D. B. (2020). YOUDEN’S TEST OF THE CHROMATOGRAPHIC DETERMINATION OF ATENOLOL IN PHARMACEUTICALS. Medical and Clinical Chemistry, (2), 61–65. https://doi.org/10.11603/mcch.2410-681X.2020.v.i2.11361

Issue

Section

ORIGINAL INVESTIGATIONS