Method for detecting imidafenacin in human plasma through HPLC-MS/MS combination

Abstract

The invention relates to a method for detecting imidafenacin in human plasma through HPLC-MS / MS combination, and belongs to the field of biological analysis. The detection method comprises the following steps: (1) pretreatment of a human plasma sample; (2) liquid chromatography-mass spectrometry combined detection: a mobile phase A and a mobile phase B are adopted as a mixed mobile phase for gradient elution, the mobile phase A is acetonitrile, and the mobile phase B is an ammonium acetate aqueous solution; and (3) measurement of the concentration of imidafenacin in human plasma. According tothe method, with imidafenacin-d10 as an internal standard, gradient elution is carried out by adopting Waters, ACQUITY UPLC BEH C8 chromatographic columns, the deuterated internal standard and a to-be-detected object have the same retention time, chemical property and matrix effect, and the reproducibility and accuracy for detecting the concentration of imidafenacin in blood plasma are relativelygood. The method provided by the invention can be used for evaluating the bioequivalence of each dosage form of imidafenacin.

Description

technical field [0001] The invention belongs to the field of biological analysis, in particular to a method for detecting the concentration of midanacin in blood plasma by liquid mass spectrometry. Background technique [0002] Midanacin is a new type of diphenylbutyramide muscarinic M1 / M3 receptor blocker with high bladder selectivity, used for the treatment of overactive bladder (Overactive Active Bladder,OAB). It selectively acts on the muscarinic M1 and M3 receptors of the bladder, blocks the contraction of acetylcholine on the detrusor muscle, relaxes the detrusor muscle, and can significantly improve urgency, frequency, and incontinence caused by overactive bladder symptom. Overactive bladder syndrome (overactive bladder syndrome, OAB) is a common urological disease, and with voiding disorder as the clinical characteristics, mainly clinical syndromes such as frequent urination, urgency, and urge urinary incontinence. The incidence of OAB increases with age, so it has...

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Problems solved by technology

[0003] At present, domestic literature only reports the technology of determining the content of midanacin by liquid chromatography. The mobile phase used is a non-volatile salt and cannot be used for mass spectrometry analysis. The limit of quantification cannot reach the plasma concentration of midanacin in the body. It takes a long time and is not suitable for the detection of large batches of biological samples

[0004] In view of the fact that there is no new in vivo drug analysis method for midanate in China, in order to meet the needs of clinical large-scale sample analysis and evaluation of drug bioequivalence, it is necessary to develop simpler, reliable, and high-throughput sample pretreatment methods and methods for testing human Method for Midanacin Concentration in Plasma

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