Direct comparison of LC-MS/MS and RIA methods for the pharmacokinetics assessment of human insulin in preclinical development
Autor: | Changxiao Liu, Yuan Gu, Duanyun Si, Guangli Wei, Shiqi Dong |
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Rok vydání: | 2018 |
Předmět: |
Male
0301 basic medicine medicine.medical_treatment Clinical Biochemistry Radioimmunoassay Endogeny Pharmacology 01 natural sciences Biochemistry Analytical Chemistry 03 medical and health sciences Dogs Pharmacokinetics Limit of Detection Tandem Mass Spectrometry In vivo Insulin Regular Human Diabetes mellitus Drug Discovery Lc ms ms medicine Human insulin Animals Humans Molecular Biology Chromatography Chemistry Insulin 010401 analytical chemistry Reproducibility of Results General Medicine medicine.disease 0104 chemical sciences 030104 developmental biology Linear Models Female Chromatography Liquid |
Zdroj: | Biomedical Chromatography. 32:e4323 |
ISSN: | 0269-3879 |
Popis: | Insulin is an effective therapeutic for diabetes, and the level of insulin in vivo is directly related to the health of diabetic patients. Traditionally, the concentrations of insulin in vivo are determined by the radioimmunoassay (RIA) method. In this study, we developed an LC-MS/MS method for the quantification of human insulin in dog plasma and directly compared the RIA and LC-MS/MS methods. Our LC-MS/MS method exhibited superior accuracy, efficiency and cost-effective for the pharmacokinetic (PK) assessment of human insulin. The LC-MS/MS method can quantitate human insulin and canine insulin simultaneously without cross-reactivity, making the analysis more efficient. The LLOQ of our LC-MS/MS method was 38.5 pg/mL, which was necessary to fully describe the PK profiles of endogenous and exogenous insulin in vivo. The direct comparison of PK data obtained from the two methods demonstrated that LC-MS/MS could be an alternative to the RIA method and should be widely used for the quantification of insulin drugs, especially in preclinical studies. |
Databáze: | OpenAIRE |
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