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Application of Design of NAUKA
Experiments in robustness study
OF CYCLOSPORINE A DETERMINATION IN RABBIT OCULAR TISSUES WITH THE USE OF
UHPLC-DAD TECHNIQUE
In accordance with international guidelines, strict validation requirements for analytical and bioanalytical meth-
ods have to be applied. Therefore, it is recommended to test robustness parameter and to properly document
it during validation studies. This paper presents various approaches of the robustness assessment with following
stages during such investigation. A worked-out example of a robustness case study for method of cyclosporine
A determination in rabbit eye tissues is given with application of novel Design of Experiments approach (DoE).
ANALITYKA – NUMER 1, ROK (XVIII) 2017 5
