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Detection method and application of vortioxetine hydrobromide and related substances thereof

A vortioxetine hydrobromide and detection method technology, applied in the field of drug analysis, can solve problems such as poor resolution, poor reproducibility, and weak specificity, and achieve the effect of quality assurance and good specificity

Active Publication Date: 2020-09-22
SHANXI ZHENDONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008] The first object of the present invention is to provide the detection method of vortioxetine hydrobromide and related substances thereof, to solve technical problems such as poor reproducibility, weak specificity, and poor resolution existing in the prior art

Method used

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  • Detection method and application of vortioxetine hydrobromide and related substances thereof
  • Detection method and application of vortioxetine hydrobromide and related substances thereof

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Embodiment 1

[0057] The present embodiment provides the detection method of vortioxetine hydrobromide and its related substances, comprising the following steps:

[0058] (1) mix reference substance solution and need testing solution

[0059] Preparation of mixed reference substance solution: Precisely weigh vortioxetine hydrobromide reference substance, related substance E, related substance F, related substance G, related substance H, related substance I, related substance K, related substance L, related substance M, appropriate amount of related substances N, dissolved and diluted with acetonitrile-water (volume ratio 1:1) to make about 1mg per 1mL of vortioxetine hydrobromide, containing related substances E, related substances F, and related substances G 1. A mixed reference substance solution of about 10 μg each of related substance H, related substance I, related substance K, related substance L, related substance M and related substance N;

[0060] Preparation of the test solution...

Embodiment 2

[0076] This embodiment refers to the detection method of Example 1, the only difference is: in the high performance liquid chromatography detection condition of step (2), the flow rate is 0.8mL / min.

Embodiment 3

[0078] This embodiment refers to the detection method of Example 1, the only difference is: in the high performance liquid chromatography detection condition of step (2), the flow rate is 1.2mL / min.

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Abstract

The invention relates to the technical field of pharmaceutical analysis, in particular to a detection method and application of vortioxetine hydrobromide and related substances thereof. The detectionmethod vortioxetine hydrobromide and related substances thereof comprises the following steps: detecting a test solution by adopting high performance liquid chromatography, wherein the detection conditions of the chromatography are as follows: the detection wavelength is 202-210 nm, the mobile phase A is a phosphoric acid aqueous solution, and the mobile phase B is acetonitrile and / or methanol; and carrying out certain gradient elution by adopting the mobile phase A and the mobile phase B. According to the detection method, vortioxetine hydrobromide and nine related substances can be efficiently separated at a time, good specificity, repeatability and accuracy are achieved on the basis that efficient separation of all the related substances and effective components is guaranteed, and quality control over vortioxetine hydrobromide related preparations is better achieved.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a detection method and application of vortioxetine hydrobromide and related substances. Background technique [0002] Vortioxetine Hydrobromide, chemical name 1-[2-(2,4-dimethylphenylthio)phenyl]piperazine hydrogen bromide, its molecular formula is C 18 h 23 BrN 2 S, molecular weight 379.36, CAS number 960203-27-4, no stereo configuration, its structural formula is: [0003] [0004] Vortioxetine hydrobromide is a new type of antidepressant developed by Lundbeck of Denmark and Takeda Pharmaceutical Company of Japan for the treatment of depression and anxiety. On September 30, 2013, it was approved by the US FDA for marketing under the trade name Brintellix for the treatment of severe depression in adults. In October of the same year, the marketing authorization application for vortioxetine received a positive opinion from the Human Medicinal Products Committee (CHMP)...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/74G01N30/8679G01N2030/047
Inventor 解晓冬游蓉丽张辉李建伟宋素丽
Owner SHANXI ZHENDONG PHARMA
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