A validated LC-MS/MS method for the quantitative measurement of creatinine as an endogenous biomarker in human plasma

被引：11

作者：

Zhao, Yue ^{[1
]}

Liu, Guowen ^{[2
]}

Angeles, Aida ^{[1
]}

Christopher, Lisa J. ^{[3
]}

Wang, Zhaoqing ^{[4
]}

Arnold, Mark E. ^{[1
]}

Shen, Jim X. ^{[1
]}

机构：

[1] Bristol Myers Squibb Co, Analyt & Bioanalyt Operat, Res & Dev, Rt 206 & Provinceline Rd, Princeton, NJ 08543 USA

[2] Agios Pharmaceut, DMPK Clin Bioanalyt, 88 Sidney St, Cambridge, MA 02139 USA

[3] Bristol Myers Squibb Co, Res & Dev, Dept Biotransformat, Rt 206 & Provinceline Rd, Princeton, NJ 08543 USA

[4] Bristol Myers Squibb Co, Res & Dev, Early Clin & Translat Res, 311 Pennington Rocky Hill Rd, Pennington, NJ 08534 USA

来源：

BIOANALYSIS | 2016年 / 8卷 / 19期

关键词：

endogenous biomarker; fit-for-purpose validation; LC-MS/MS; surrogate analyte; LIQUID-CHROMATOGRAPHY; MASS-SPECTROMETRY;

D O I：

10.4155/bio-2016-0086

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

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.

引用

页码：1997 / 2005

页数：9

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