کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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1163973 | 1490962 | 2015 | 16 صفحه PDF | دانلود رایگان |
• The status of validation of LC–MS methods is comprehensively reviewed.
• Clarity is brought into validation-related terminology.
• Recommendations on difficult validation-related issues in LC–MS are given.
This is the part I of a tutorial review intending to give an overview of the state of the art of method validation in liquid chromatography mass spectrometry (LC–MS) and discuss specific issues that arise with MS (and MS/MS) detection in LC (as opposed to the “conventional” detectors). The Part I briefly introduces the principles of operation of LC–MS (emphasizing the aspects important from the validation point of view, in particular the ionization process and ionization suppression/enhancement); reviews the main validation guideline documents and discusses in detail the following performance parameters: selectivity/specificity/identity, ruggedness/robustness, limit of detection, limit of quantification, decision limit and detection capability. With every method performance characteristic its essence and terminology are addressed, the current status of treating it is reviewed and recommendations are given, how to determine it, specifically in the case of LC–MS methods.
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Journal: Analytica Chimica Acta - Volume 870, 22 April 2015, Pages 29–44