Method for detecting lurasidone by applying ultra-high performance liquid chromatography-tandem mass spectrometry

A technology of ultra-high performance liquid phase and tandem mass spectrometry, applied in measurement devices, instruments, scientific instruments, etc., can solve the problems of side reaction impurities, incomplete removal of impurities, affecting the purity and quality of drugs, etc., to reduce the detection limit, avoid Matrix interference and the effect of improving detection sensitivity

Pending Publication Date: 2021-06-18
江苏乾元生物科技有限公司
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  • Abstract
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AI Technical Summary

Problems solved by technology

[0003] During the synthesis of lurasidone hydrochloride, the impurities in the intermediates are not completely removed, which will cause side reactions and the generation of impurities, thus affecting the purity and quality of the drug

Method used

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Embodiment Construction

[0018] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are part of the present invention Examples, not all examples.

[0019] The invention provides a method for detecting lurasidone using ultra-high performance liquid chromatography-tandem mass spectrometry, comprising the following steps:

[0020] Step (1), take 0.01-0.06g of the sample to be tested, accurate to 0.01mg, put it in a volumetric flask, add acetonitrile-water (3-9):2 to make it 10-50ml, vortex mix for 7-13min, Ultrasonic extraction for 7 to 13 minutes, passing through a 0.22 μm filter membrane, and injecting a sample to detect lurasidone in the sample;

[0021] In step (2), lurasidone is detected by using ultra-high performance liqu...

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Abstract

The invention relates to a method for detecting lurasidone by using ultra-high performance liquid chromatography-tandem mass spectrometry. The method comprises the following steps: (1), putting a sample to be detected into a volumetric flask, adding acetonitrile-water (3-9): 2 to fix the volume to 10-50 ml, carrying out vortex mixing for 7-13 min, carrying out ultrasonic extraction for 7-13 min, passing through a 0.22 [mu]m filter membrane, and injecting the sample to detect lurasidone in the sample; and (2) detecting the lurasidone by adopting an ultra-high performance liquid chromatograph-tandem mass spectrometer (UPLC-MS / MS) as a detection instrument. The detection method has the advantages of good selectivity, high sensitivity, simplicity, rapidness and the like. By using UPLC-MS / MS, the lurasidone in bulk drugs, pharmaceutical preparations and other samples can be rapidly and efficiently tested in a limited manner; and the detection sensitivity of the lurasidone can be effectively improved, matrix interference is effectively avoided, and the detection limit of the lurasidone is reduced.

Description

technical field [0001] The invention relates to the application field of high-performance liquid chromatography technology, in particular to a method for detecting lurasidone by using ultra-high performance liquid chromatography-tandem mass spectrometry. Background technique [0002] Lurasidone hydrochloride (lurasidone hydrochloride) is a novel antipsychotic drug with dual effects developed by Sumitomo Pharmaceutical Co., Ltd. of Japan. 2A receptors and dopamine D 2 The receptors all have high affinity and have significant curative effect on both positive and negative symptoms of psychotic patients. [0003] During the synthesis of lurasidone hydrochloride, the incomplete removal of impurities in its intermediates will cause side reactions and the generation of impurities, thereby affecting the purity and quality of the drug. Therefore, realizing the separation and determination of lurasidone hydrochloride intermediates and related substances can ensure the purity of reac...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/06
CPCG01N30/06G01N30/88
Inventor 刘长生肖石基
Owner 江苏乾元生物科技有限公司
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