Simultaneous determination of imigliptin and its three metabolites in human plasma and urine by liquid chromatography coupled to tandem mass spectrometry

Liu, Yang; Liu, Dongyang; Li, Hongzhong; Hong-tao, Song; Song, Lin; Yao, Xinglei; Wu, Frank; Shu, Chutian; Ma, Xiaochi; Zhou, Huimin; Jiang, Ji; Hu, Pei

doi:10.1016/j.jchromb.2015.08.003

Cited by 2 publications

(2 citation statements)

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“…The extracted cartridges were activated with methanol firstly followed by balancing with 2% formic acid to enhance the retention of the targeted compounds which were kept in cation formation. Because two new analytes will be analyzed in the new method, rinsing and eluting steps were optimized as previously published studies to achieve the highest recovery with the lowest interference of all analytes (Liu et al, 2015). The result suggested that methanol/water (20/80, v/v) with or without 2% formic acid was the solution to meet both conditions: the highest water component and the lowest elution capability for targeted compounds.…”

Section: Methods Applicationmentioning

confidence: 99%

“…Previously, a robust method simultaneously measuring imigliptin and its three metabolites in human plasma and urine has been developed to achieve the pharmacokinetic profiles in single escalation dose study (Liu et al, 2015). Although the developed method has been approved to evaluate PK characters of imigliptin in humans, one of the measured metabolites, KBP-5493, was interfered by the other drugrelated substance in plasma at high dose levels.…”

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confidence: 99%

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A high‐performance liquid chromatography–tandem mass spectrometry method for simultaneous determination of imigliptin, its five metabolites and alogliptin in human plasma and urine and its application to a multiple‐dose pharmacokinetic study

Liu

Lee

Yao

et al. 2018

Biomedical Chromatography

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Imigliptin is a novel DPP-4 inhibitor, designed to treat type 2 diabetes mellitus (T2DM). A selective and sensitive method was developed using high performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS) to simultaneously quantify imigliptin, its five metabolites, and alogliptin in human plasma and urine. Solid-phase extraction (SPE) and direct dilution were used to extract imigliptin, its five metabolites, alogliptin from plasma and urine, respectively. The extracts were injected onto a SymmetryShield RP column with a gradient elution of methanol and water containing 10 mM ammonium formate (pH = 7). Ionization of all analytes was performed using an electrospray ionization (ESI) source in positive mode and detection was carried out with multiple reaction monitoring (MRM) mode. The results revealed that the method had excellent selectivity and linearity. Inter- and intra-batch precisions of all analytes were less than 15% and the accuracies were within 85%-115% for both plasma and urine. The sensitivity, matrix effect, extraction recovery, linearity, and stabilities were validated for all analytes in human plasma and urine. In conclusion, the validation results showed that this method was robust, specific, and sensitive and it can successfully applied to a pharmacokinetic study of Chinese T2DM subjects after oral dose of imigliptin and alogliptin.

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Section: Methods Applicationmentioning

confidence: 99%

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confidence: 99%