Development of a LC–MS/MS analytical method of 15 compounds related to renal function for a prognostic method of progression risk in patients with diabetic kidney disease

Diabetic kidney disease (DKD) onset and progression is a major cause of end-stage renal failure in diabetic patients, however, no practical method has been reported to predict the progression rate of renal function decline. Nine serum compounds are reported to associate with prognosis in type 1 diab...

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Main Authors: Ryota Kujirai, Yotaro Matsumoto, Mizuki Abe, Kodai Hiramoto, Takumi Watanabe, Chitose Suzuki, Takafumi Toyohara, Takaaki Abe, Yoshihisa Tomioka
Format: Article
Language:English
Published: Elsevier 2023-12-01
Series:Journal of Pharmaceutical and Biomedical Analysis Open
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Online Access:http://www.sciencedirect.com/science/article/pii/S2949771X2300021X
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author Ryota Kujirai
Yotaro Matsumoto
Mizuki Abe
Kodai Hiramoto
Takumi Watanabe
Chitose Suzuki
Takafumi Toyohara
Takaaki Abe
Yoshihisa Tomioka
author_facet Ryota Kujirai
Yotaro Matsumoto
Mizuki Abe
Kodai Hiramoto
Takumi Watanabe
Chitose Suzuki
Takafumi Toyohara
Takaaki Abe
Yoshihisa Tomioka
author_sort Ryota Kujirai
collection DOAJ
description Diabetic kidney disease (DKD) onset and progression is a major cause of end-stage renal failure in diabetic patients, however, no practical method has been reported to predict the progression rate of renal function decline. Nine serum compounds are reported to associate with prognosis in type 1 diabetes patients; however, quantitative analytical methods for these compounds lacks. Herein, we developed a simultaneous quantitative method for 15 compounds, including Niewczas’s nine biomarker candidates, associated with renal function and its prognosis in kidney disease patients to achieve a prognostic method of renal function decline in DKD patients. This report describes the development and validation of a LC–MS/MS analytical method for 15 compounds of biomarker candidates using human plasma, serum, and urine as sample matrices. The analytes are N-acetyl-L-alanine, N6-acetyl-L-lysine, N-acetyl-L-serine, N-acetyl-L-threonine, phenyl sulfate, pseudouridine, N6-threonylcarbamoyladenosine, tryptophan 2-C-mannoside, tyrosine O-sulfate, creatinine, p-cresol sulfate, 4-ethylphenyl sulfate, indoxyl sulfate, N1-methyladenosine, and trimethylamine N-oxide. The Capcell Pak ADME-HR column was compared to several general columns and selected as the most suitable column for the simultaneous analysis of all 15 compounds. The proposed method was validated for selectivity, accuracy, precision, stability, dilution integrity, and parallelism. This report describes the suitability of the calibration ranges established and the actual sample concentrations of serum and urine from type 2 diabetic patients, as well as new findings on the unknown analyte levels of several compounds in these samples. The proposed method can be used to aid the development of prognostic methods for renal function decline in patients with DKD.
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spelling doaj-art-442e5c4b77fc4a29a8338e9b89955db22025-08-20T03:42:52ZengElsevierJournal of Pharmaceutical and Biomedical Analysis Open2949-771X2023-12-01210002110.1016/j.jpbao.2023.100021Development of a LC–MS/MS analytical method of 15 compounds related to renal function for a prognostic method of progression risk in patients with diabetic kidney diseaseRyota Kujirai0Yotaro Matsumoto1Mizuki Abe2Kodai Hiramoto3Takumi Watanabe4Chitose Suzuki5Takafumi Toyohara6Takaaki Abe7Yoshihisa Tomioka8Laboratory of Oncology, Pharmacy Practice and Sciences, Tohoku University Graduate School of Pharmaceutical Sciences, 6–3, Aoba, Aramaki, Aoba-ku, Sendai 980–8578, JapanLaboratory of Oncology, Pharmacy Practice and Sciences, Tohoku University Graduate School of Pharmaceutical Sciences, 6–3, Aoba, Aramaki, Aoba-ku, Sendai 980–8578, Japan; Corresponding author.Laboratory of Oncology, Pharmacy Practice and Sciences, Tohoku University Graduate School of Pharmaceutical Sciences, 6–3, Aoba, Aramaki, Aoba-ku, Sendai 980–8578, JapanLaboratory of Oncology, Pharmacy Practice and Sciences, Tohoku University Graduate School of Pharmaceutical Sciences, 6–3, Aoba, Aramaki, Aoba-ku, Sendai 980–8578, JapanLaboratory of Oncology, Pharmacy Practice and Sciences, Tohoku University Graduate School of Pharmaceutical Sciences, 6–3, Aoba, Aramaki, Aoba-ku, Sendai 980–8578, JapanDivision of Nephrology and Hypertension, Tohoku University Hospital, 1–1, Seiryo-machi, Aoba-ku, Sendai 980–8574, JapanDivision of Nephrology and Hypertension, Tohoku University Hospital, 1–1, Seiryo-machi, Aoba-ku, Sendai 980–8574, Japan; Division of Medical Science, Tohoku University Graduate School of Biomedical Engineering, 6–6–12, Aoba, Aramaki, Aoba-ku, Sendai 980–8579, JapanDivision of Nephrology and Hypertension, Tohoku University Hospital, 1–1, Seiryo-machi, Aoba-ku, Sendai 980–8574, Japan; Division of Medical Science, Tohoku University Graduate School of Biomedical Engineering, 6–6–12, Aoba, Aramaki, Aoba-ku, Sendai 980–8579, Japan; Department of Clinical Biology and Hormonal Regulation, Tohoku University Graduate School of Medicine, 2–1, Seiryo-machi, Aoba-ku, Sendai, 980–8575, JapanLaboratory of Oncology, Pharmacy Practice and Sciences, Tohoku University Graduate School of Pharmaceutical Sciences, 6–3, Aoba, Aramaki, Aoba-ku, Sendai 980–8578, JapanDiabetic kidney disease (DKD) onset and progression is a major cause of end-stage renal failure in diabetic patients, however, no practical method has been reported to predict the progression rate of renal function decline. Nine serum compounds are reported to associate with prognosis in type 1 diabetes patients; however, quantitative analytical methods for these compounds lacks. Herein, we developed a simultaneous quantitative method for 15 compounds, including Niewczas’s nine biomarker candidates, associated with renal function and its prognosis in kidney disease patients to achieve a prognostic method of renal function decline in DKD patients. This report describes the development and validation of a LC–MS/MS analytical method for 15 compounds of biomarker candidates using human plasma, serum, and urine as sample matrices. The analytes are N-acetyl-L-alanine, N6-acetyl-L-lysine, N-acetyl-L-serine, N-acetyl-L-threonine, phenyl sulfate, pseudouridine, N6-threonylcarbamoyladenosine, tryptophan 2-C-mannoside, tyrosine O-sulfate, creatinine, p-cresol sulfate, 4-ethylphenyl sulfate, indoxyl sulfate, N1-methyladenosine, and trimethylamine N-oxide. The Capcell Pak ADME-HR column was compared to several general columns and selected as the most suitable column for the simultaneous analysis of all 15 compounds. The proposed method was validated for selectivity, accuracy, precision, stability, dilution integrity, and parallelism. This report describes the suitability of the calibration ranges established and the actual sample concentrations of serum and urine from type 2 diabetic patients, as well as new findings on the unknown analyte levels of several compounds in these samples. The proposed method can be used to aid the development of prognostic methods for renal function decline in patients with DKD.http://www.sciencedirect.com/science/article/pii/S2949771X2300021XDiabetic kidney diseaseProgressive renal declineStable isotope-labeled internal standardValidationLC–MS/MS
spellingShingle Ryota Kujirai
Yotaro Matsumoto
Mizuki Abe
Kodai Hiramoto
Takumi Watanabe
Chitose Suzuki
Takafumi Toyohara
Takaaki Abe
Yoshihisa Tomioka
Development of a LC–MS/MS analytical method of 15 compounds related to renal function for a prognostic method of progression risk in patients with diabetic kidney disease
Journal of Pharmaceutical and Biomedical Analysis Open
Diabetic kidney disease
Progressive renal decline
Stable isotope-labeled internal standard
Validation
LC–MS/MS
title Development of a LC–MS/MS analytical method of 15 compounds related to renal function for a prognostic method of progression risk in patients with diabetic kidney disease
title_full Development of a LC–MS/MS analytical method of 15 compounds related to renal function for a prognostic method of progression risk in patients with diabetic kidney disease
title_fullStr Development of a LC–MS/MS analytical method of 15 compounds related to renal function for a prognostic method of progression risk in patients with diabetic kidney disease
title_full_unstemmed Development of a LC–MS/MS analytical method of 15 compounds related to renal function for a prognostic method of progression risk in patients with diabetic kidney disease
title_short Development of a LC–MS/MS analytical method of 15 compounds related to renal function for a prognostic method of progression risk in patients with diabetic kidney disease
title_sort development of a lc ms ms analytical method of 15 compounds related to renal function for a prognostic method of progression risk in patients with diabetic kidney disease
topic Diabetic kidney disease
Progressive renal decline
Stable isotope-labeled internal standard
Validation
LC–MS/MS
url http://www.sciencedirect.com/science/article/pii/S2949771X2300021X
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