Open AccessINTER-LABORATORY REPRODUCIBILITY OF BIOANALYTICAL UHPLC-MS/MS METHOD
Author(s) -
Biljana K. TubiÄ,
Sandra Vladimirov,
Bojan D. MarkoviÄ
Publication year - 2017
Publication title -
advanced quality
Language(s) - English
Resource type - Journals
eISSN - 2217-8538
pISSN - 2217-8155
DOI - 10.25137/ijaq.n2.v45.y2017.p49-53
Subject(s) - transferability , bioanalysis , reproducibility , computer science , process (computing) , chromatography , chemistry , machine learning , logit , operating system
Method validation is a continuous process, as a part of a perpetual analytical method development and improvement. Requirements for full validation are defined by various guidelines. Nevertheless, partial validation and method transfer are not so clearly described and well defined.The aim of this study was to examine method transferability through full validation method transfer between two different laboratories and to demonstrate if this approach can be regarded as sufficient for cross-laboratory results comparison.Method transfer was done from the originator laboratory to the recipient laboratory on two UHPLC-MS/MS instruments of approximately the same technical characteristics. The developed quantitative method was validated on both instruments by taking into account selectivity, linearity, accuracy, precision, limit of quantitation, recovery, matrix effects and stability in accordance with the regulatory guidance/guideline. Also method comparison by Passing-Bablok regression analysis was done.The reproducibility and cross-laboratory transferability of the UHPLC-MS/MS method for future non-clinical study was proven.As an epilogue to this study, authors recommend for the method transfer to be implemented in future in-house standard operating procedures (SOPs) related to analytical method validation process.