Robustness evaluation of the chromatographic determination of verapamil hydrochloride
DOI:
https://doi.org/10.11603/mcch.2410-681X.2017.v0.i1.7244Keywords:
verapamil hydrochloride, validation, robustness, chromatography, quantitative analysis, Youden’s test.Abstract
The aim of this study was the rubustness evaluation of the chromatographic determination of verapamil hydrochloride using Youden’s test.
Methods: Youden’s test is a reliable method to evaluate the robustness of analytical methods, by means of an experiment design which involves seven analytical parameters combined in eight tests. In the present study, we assessed the robustness of a chromatographic method to quantify verapamil hydrochloride using Youden’s test. Hence, it was possible to determine the effect of each analytical parameter in the final analysis results. Youden’s test showed to be a simple and feasible procedure to evaluate the robustness of chromatographic methods.
Results: Using the criteria of Youden’s test, the chromatographic method showed to be highly robust regarding the verapamil hydrochloride content, when variations in seven analytical parameters were introduced. The highest variation in the verapamil hydrochloride content was 0.26 %, when the concentration of triethylamine in the mobile phase was altered; a value considerably low and not significant in routine analyses.
Conclusion: Youden’s test showed to be a reliable and useful tool for the robustness evaluation of the chromatographic method for verapamil hydrochloride quantitation. By means of this test, it was possible to evaluate the effect of seven analytical parameters in the final result of the analyses. Therefore, Youden’s test can be successfully applied for the robustness evaluation in validation process of analytical methods by HPLC.
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