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Method for detecting impurity K in ganciclovir and method for separating impurity

A detection method and technology of ganciclovir are applied in the detection of impurity K in ganciclovir and the field of separation of impurities to achieve the effects of high recovery rate, good repeatability and good precision

Pending Publication Date: 2022-01-14
武汉九州钰民医药科技有限公司
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  • Application Information

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Problems solved by technology

[0007] The technical problem to be solved by the present invention is to overcome the defect that there is no method for simultaneously realizing the separation of impurity K and the complete elution of other known impurities in the detection of related substances of ganciclovir in the prior art, and provides a more The detection method of impurity K in ciclovir, and the separation method of impurity

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  • Method for detecting impurity K in ganciclovir and method for separating impurity
  • Method for detecting impurity K in ganciclovir and method for separating impurity
  • Method for detecting impurity K in ganciclovir and method for separating impurity

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Embodiment 1

[0053] A kind of detection method of impurity K in the ganciclovir crude drug, concrete steps are as follows:

[0054] 1. Solution preparation

[0055] Need testing solution: take about 15 mg of ganciclovir crude drug, accurately weighed, put in a 50 ml measuring bottle, add mobile phase A to dissolve and dilute to the scale, shake well, and get final product.

[0056] Reference substance solution: take about 15 mg of the impurity K reference substance, weigh it accurately, put it in a 100ml measuring bottle, add mobile phase A to dissolve and dilute to the mark, shake well; accurately measure 1ml, put it in a 100ml measuring bottle, and use mobile phase A Dilute to the mark, shake well, accurately measure 1ml, put it in a 10ml measuring bottle, dilute to the mark with mobile phase A, shake well, and you get it.

[0057] 2. Chromatographic conditions

[0058] Chromatographic column: Yuexu AQ-C18 250×4.6mm, 5μm

[0059] Mobile phase: Mobile phase A: Take about 1.38g of ammon...

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Abstract

The invention discloses a method for detecting an impurity K in ganciclovir and a method for separating the impurity. The method comprises the following steps: detecting a test solution containing ganciclovir by adopting high performance liquid chromatography, wherein a chromatographic column adopted by the high performance liquid chromatography is a cation exchange chromatographic column, mobile phases comprise a mobile phase A and a mobile phase B, and the mobile phase A is a phosphoric acid aqueous solution containing 0.012 M ammonium dihydrogen phosphate, in the phosphoric acid aqueous solution, the volume percent of phosphoric acid is 0.12%, the mobile phase B is acetonitrile. In combination with a specific elution mode, the method not only can realize effective separation and detection of the impurity K, but also can completely elute other known impurities, and is beneficial to the service life of a chromatographic column.

Description

technical field [0001] The invention relates to a method for detecting impurity K in ganciclovir and a method for separating the impurity. Background technique [0002] Ganciclovir is a nucleoside antiviral drug, which is known to contain impurities A, B, C, D, E, F, H, I, J, L, M, N, R, and the specific structures of these impurities as follows: [0003] [0004] [0005] [0006] Wherein, impurity K is a possible degradation impurity, which is difficult to separate from the peak of ganciclovir under the conditions of related substances. Therefore, it is necessary to establish a separate method to control the impurity K, and at the same time to elute other known impurities, so as not to cause other impurities to remain in the chromatographic column, affecting subsequent operations and the life of the chromatographic column. However, among the related substance detection methods of ganciclovir, a method that can simultaneously realize the separation and detection ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/60
CPCG01N30/02G01N30/06G01N30/34G01N30/60
Inventor 苏立林姚萍余艳平刘均均柳少群陈龙龚丹凤范昭泽胡仁军
Owner 武汉九州钰民医药科技有限公司
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