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Detection method and application of vortioxetine hydrobromide and its related substances

A technology of vortioxetine hydrobromide and a detection method, applied in the field of drug analysis, can solve problems such as poor resolution, poor specificity, poor reproducibility, etc., and achieve the effects of quality assurance, good specificity, and efficient separation

Active Publication Date: 2022-05-13
SHANXI ZHENDONG PHARMA
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  • 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 its related substances
  • Detection method and application of vortioxetine hydrobromide and its related substances
  • Detection method and application of vortioxetine hydrobromide and its related substances

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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 drug analysis, in particular to a detection method and application of vortioxetine hydrobromide and related substances. The detection method of vortioxetine hydrobromide and related substances thereof comprises the steps of: adopting high performance liquid chromatography to detect the need testing solution; the detection conditions of the chromatography include: detection wavelength is 202~210nm; mobile phase A is phosphoric acid Aqueous solution, mobile phase B is acetonitrile and / or methanol; using the mobile phase A and mobile phase B to carry out a certain gradient elution. The detection method of the present invention can realize one-time efficient separation of vortioxetine hydrobromide and 9 kinds of related substances, and on the basis of ensuring the efficient separation of each related substance and active ingredients, it has good specificity, repeated accuracy and accuracy, and better realize the quality control of vortioxetine hydrobromide-related preparations.

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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Patent Type & Authority Patents(China)
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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