A validated LC–MS/MS method for the quantitative measurement of creatinine as an endogenous biomarker in human plasma. (October 2016)

• Record Type: Journal Article
• Authors: Zhao, Yue; Liu, Guowen; Angeles, Aida; Christopher, Lisa J; Wang, Zhaoqing; Arnold, Mark E; Shen, Jim X
• Is Part Of: Bioanalysis. Volume 8:Number 19(2016)
• Page Start: 1997
• Page End: 2005
• Publication Date: 2016-10
• Subjects: endogenous biomarker -- fit-for-purpose validation -- LC–MS/MS -- surrogate analyte; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2016-0086
• Languages: English
• ISSNs: 1757-6180

Abstract

Background: Creatinine is an endogenous compound generated from creatine by normal muscular metabolism. It is an important indicator of renal function and the serum level is routinely monitored in clinical labs.Results & methodology: Surrogate analyte (d3-creatinine) was used for calibration standard and quality control preparation and the relative instrument response ratio between creatinine and d3-creatinine was used to calculate the endogenous creatinine concentrations.Conclusion: A fit-for-purpose strategy of using a surrogate analyte and authentic matrix was adopted for this validation. The assay was the first human plasma assay using such strategy and was successfully applied to a clinical study to confirm a transient elevation of creatinine observed using an existing clinical assay.