A kind of method for measuring each degradation impurity in fluvoxamine maleate

A technology of fluvoxamine maleate and maleic acid, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of difficult implementation, high cost, and difficult purchase price according to the product, and achieve good application value and accurate The effect of high degree of popularity and popularization

Active Publication Date: 2021-04-23
广东省药品检验所
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0010] In order to make up for the specificity and accuracy of the method in the existing detection standards, and to avoid the disadvantages that the method is difficult to implement because the reference substance is difficult to purchase or the price is too expensive

Method used

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  • A kind of method for measuring each degradation impurity in fluvoxamine maleate
  • A kind of method for measuring each degradation impurity in fluvoxamine maleate
  • A kind of method for measuring each degradation impurity in fluvoxamine maleate

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Effect test

Embodiment 1

[0064] Embodiment 1 A kind of method for measuring each degradation impurity in fluvoxamine maleate

[0065] Impurity Ⅰ (see Table 1) in fluvoxamine maleate is a process impurity; Impurities Ⅱ~Ⅴ (see Table 1) are degraded impurities, which will be degraded to varying degrees under various damage conditions; according to the structural characteristics of the product, Among them, impurity II, impurity III, impurity IV, and impurity V are the main degradation impurities. Through various destruction experiments, it was shown that impurity II, impurity III and impurity IV could be destroyed by using fluvoxamine maleate reference substance. And through repeated tests, when the fluvoxamine maleate reference substance was destroyed by the inventive method, the interference impurity was less (from figure 1 It can be seen from the figure that when the USP destruction method is used, there is an interference peak with the same peak area before the impurity III, which will cause position...

Embodiment 2

[0085] Embodiment 2 A kind of method for measuring each degradation impurity in fluvoxamine maleate

[0086] 1) Take about 15 mg of fluvoxamine maleate standard product (available in China), put it in a headspace bottle, add 10 mg of maleic acid, dissolve it with 2 ml of methanol-water (volume ratio 55:45), and then add 0.2mol / L potassium hydroxide solution 1ml, sealed, heated in water bath (95~100℃) for 2 hours, took out, let cool to room temperature, added 1ml of 1mol / L nitric acid solution, heated in water bath (95~100℃) for 3 minutes, put Cool to room temperature, transfer to a 10ml measuring bottle, dilute to the mark with a methanol-water (45:55) mixed solution, and shake well to obtain fluvoxamine maleate impurity II, impurity III, and fluvoxamine maleate The mixed solution of Ming and impurity IV is used as the system suitability solution (hereinafter referred to as the destruction solution).

[0087] The aforementioned destruction of impurity II, impurity III, and im...

Embodiment 3

[0096] Embodiment 3 A kind of method for measuring each degradation impurity in fluvoxamine maleate

[0097] 1) Take about 10 mg of fluvoxamine maleate standard product (available in China), put it in a headspace bottle, add 20 mg of maleic acid, dissolve it with 2 ml of ethanol-water (volume ratio 45:55), and then add 1ml of 0.2mol / L calcium hydroxide solution, sealed, heated in a water bath (95-100°C) for 0.8 hours, taken out, let cool to room temperature, added 1ml of 1mol / L nitric acid solution, heated in a water bath (95-100°C) for 3 minutes, put Cool to room temperature, transfer to a 10ml measuring bottle, dilute to the mark with a mixed solution of ethanol-water (45:55), and shake well to obtain vofloxamine maleate impurity II, impurity III, and vofloxamate maleate The mixed solution of Ming and impurity IV is used as the system suitability solution (hereinafter referred to as the destruction solution).

[0098] The aforementioned destruction of impurity II, impurity ...

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Abstract

The invention discloses a method for measuring impurities in fluvoxamine maleate. The method can directionally destroy impurities II, III and IV, and the interfering impurities are small, without affecting the positioning of each impurity, which solves USP41 ‑NF36 impurity III is susceptible to interference, and impurity IV lacks accuracy. That is, under general experimental conditions, impurity II, impurity III and impurity IV can be obtained for the positioning of impurities in the HPLC system, and at the same time, because impurity V is located between impurity II and the main component, the method of the present invention can control impurity II and the main component. The separation degree between the components is not less than 4.0, ensuring that the separation degree between the peaks of impurity II, impurity V and fluvoxamine maleate can meet the requirements. The method of the invention has strong pertinence and high accuracy, and at the same time avoids the use of expensive and difficult-to-purchase impurity reference substances, making the method easy to popularize and popularize, and has good application value.

Description

technical field [0001] The invention relates to a method for determining various degradation impurities in fluvoxamine maleate. Background technique [0002] Fluvoxamine maleate acts on the serotonin reuptake inhibitor of brain nerve cells and is clinically used for antidepressant. At present, it is produced both at home and abroad. [0003] The chemical structures of fluvoxamine maleate and its impurities Ⅰ~Ⅴ are shown in Table 1. The control methods of fluvoxamine maleate impurities are recorded in USP41-NF36, BP2018, and JP17. For this variety, there are existing regularization standards YBH34112005 (raw material) and YBH33832005 (pieces). [0004] Table 1 Structural formula of fluvoxamine maleate and impurities [0005] [0006] [0007] In the current standard, BP2018 adopts fluvoxamine maleate system usability reference substance (including impurity I, impurity II, impurity III and impurity V), and impurity IV reference substance positioning, which is highly t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 余少文
Owner 广东省药品检验所
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