Robustness evaluation of the chromatographic determination of nifedipine in pharmaceuticals
Keywords:nifedipine, validation, robustness, chromatography, quantitative analysis, Youden’s test
Topicality. Robustness tests were originally introduced to avoid problems in interlaboratory studies and to identify the potentially responsible factors.
The aim of this study was the rubustness evaluation of the chromatographic determination of nifedipine in medicines using Youden’s test.
Materials and 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 nifedipine using Youden’s test. Youden’s test showed to be a simple and feasible procedure to evaluate the robustness of chromatographic methods.
Results and discussion. Using the criteria of Youden’s test, the chromatographic method showed to be highly robust regarding of nifedipine content, when variations in seven analytical parameters were introduced. The highest variation in nifedipine content was 0.28 %, when the concentration of trifluoroacetic acid in the mobile phase was altered; a value considerably low and not significant in routine analyses.
Conclusions. Youden’s test showed to be a reliable and useful tool for the robustness evaluation of the chromatographic method for assay of nifedipine. Therefore, Youden’s test can be successfully applied for the robustness evaluation in validation process of analytical methods by HPLC.
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