Robustness Evaluation of the Chromatographic Determination of Amlodipine in Tablet Dosage Form
Journal Title: International Journal of Ayurveda and Pharmaceutical Chemistry - Year 2017, Vol 0, Issue 0
Abstract
Introduction: Robustness tests were originally introduced to avoid problems in interlaboratory studies and to identify the potentially responsible factors. The aim of this study was robustness evaluation of the chromatographic determination of amlodipine in tablet dosage form 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 amlodipine in tablets using Youden’s test. 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 highest variation in amlodipine content was 0.44 %, when the concentration of trifluoroacetic acid 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 assay of amlodipine. Therefore, Youden’s test can be successfully applied for the robustness evaluation in validation process of analytical methods by HPLC
Authors and Affiliations
Liliya Logoyda, Yuliya Kondratova, Dmytro Korobko
Keywords
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