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Method for determining acetate in sodium ozagrel raw material medicine

A technology for the determination of sodium ozagrel and its determination method, which is applied in the field of determination of acetate in the bulk drug of sodium ozagrel, can solve the problems of no acetate determination method, and achieve high intermediate precision and durability, repeatability good sex effect

Pending Publication Date: 2022-04-19
武汉九州钰民医药科技有限公司
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Problems solved by technology

However, the prior art does not have a method for the determination of acetate in ozagrel sodium raw materials

Method used

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  • Method for determining acetate in sodium ozagrel raw material medicine
  • Method for determining acetate in sodium ozagrel raw material medicine
  • Method for determining acetate in sodium ozagrel raw material medicine

Examples

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Embodiment 1

[0065] The method parameter of embodiment 1 is as shown in table 6 below:

[0066] Table 6

[0067]

[0068]

[0069] Note: The above conditions are based on Thermo Dionex ICS-5000 + Established by DP instruments, certain conditions such as running time can be adjusted according to different instruments or actual conditions.

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Abstract

The invention discloses a method for determining acetate in a sodium ozagrel raw material medicine. The determination method comprises the following step: detecting by adopting an ion chromatography method, wherein the chromatographic conditions are as follows: the chromatographic column is Thermo Dionex IonPac AS19, the column temperature is 20-30 DEG C, and the column temperature is 20-30 DEG C; the mobile phase is a KOH solution; the gradient elution is divided into three steps: the first step is that the KOH concentration is maintained to be 8-12 mmol / L within 0-(7-12) min; in the second step, the KOH concentration is maintained to be 30 mmol / L within the time from (7.1-12.1) min to (12-20) min; and in the third step, the concentration of KOH is maintained to be 8-12 mmol / L within the time range from (12.1-20.1) min to (14-30) min. According to the determination method disclosed by the invention, the content of acetate in sodium ozagrel can be accurately detected under given conditions.

Description

technical field [0001] The invention relates to a method for determining acetate in ozagrel sodium crude drug. Background technique [0002] In the synthesis process of ozagrel sodium bulk drug, acetic acid needs to be used and removed by washing with water and drying, but the residual acetic acid will be converted into acetate during the salt formation process. Therefore, it is necessary to test the content of acetate in ozagrel sodium API. However, there is no method for the determination of acetate in ozagrel sodium bulk drug in the prior art. Contents of the invention [0003] The present invention provides a method for determining acetate in ozagrel sodium raw materials in order to solve the lack of a method for measuring acetate in ozagrel sodium raw materials in the prior art. The determination method of the present invention can accurately detect the content of acetate in the ozagrel sodium under given conditions. [0004] The present invention solves the above-...

Claims

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Application Information

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IPC IPC(8): G01N30/96
CPCG01N30/96
Inventor 苏立林胡伟陈程龚丹凤余艳平范昭泽胡仁军
Owner 武汉九州钰民医药科技有限公司
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