ROBUSTNESS EVALUATION OF THE CHROMATOGRAPHIC DETERMINATION OF VALSARTAN IN PHARMACEUTICALS
The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage. The aim of the study – to evaluate the rubustness of HPLC determination of valsartan in tablets using Youden’s test. Material and Methods. An efficient method to assess the robustness of analytical methodsis 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 valsartan in tablets using Youden’s test. Results. The experimental design approach (design of experiment) is the method of simultaneous investigation of the influence of several factors on robustness of the method using a certain plan (matrix) of experiments. By using the Youden’s test criteria, HPLC method showed to be greatly robust concerning valsartan content, at the introduction of variation in seven analytic parameters. 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 valsartan by HPLC. Youden’s test can be applied successfully for the robustness evaluation in validation process of analytical methods.