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High performance liquid chromatography detection method for phosphine sodium formate and impurities thereof

A technology of high-performance liquid chromatography and sodium foscarnet, which is applied in the field of drug detection, can solve the problems of cumbersome operation and low economic benefits, and achieve the effect of simplifying the analysis method and improving the analysis efficiency

Active Publication Date: 2020-07-31
武汉药品医疗器械检验所
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

To detect impurities through two completely different detection items, the operation is more cumbersome and the economic benefit is not high

Method used

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  • High performance liquid chromatography detection method for phosphine sodium formate and impurities thereof
  • High performance liquid chromatography detection method for phosphine sodium formate and impurities thereof
  • High performance liquid chromatography detection method for phosphine sodium formate and impurities thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0037] The present embodiment provides a high-performance liquid chromatography detection method of sodium foscarnet and its impurities, including:

[0038] 1. Chromatographic conditions

[0039] Chromatographic column: Shiseido PAK C18 chromatographic column (250mm×4.6mm, 5μm).

[0040] Mobile phase: Take 1.42g of anhydrous sodium sulfate, add 3mL of glacial acetic acid and 6mL of 0.1mol / L sodium pyrophosphate solution, add 1000mL of water to dissolve, as solution A; take 1.42g of anhydrous sodium sulfate, add 4.2g of anhydrous sodium acetate Dissolve 6mL of 0.1mol / L sodium pyrophosphate solution with 1000mL of water and make solution B; take 1000mL of solution A-solution B (70:30) mixed solution (pH value is about 4.4), add 0.25g of tetrahexyl ammonium bisulfate , Shake to dissolve, add methanol 100mL, shake well.

[0041] Flow rate: 1.0 mL / min.

[0042] Column temperature: 35°C.

[0043] Wavelength: 230nm.

[0044] 2. Solution Preparation

[0045] ①The test solution t...

experiment example

[0070] According to the chromatographic method described in this example, 3 batches of sodium foscarnet samples from a pharmaceutical manufacturer in Jinan were inspected for related substances, and no impurity peaks were detected in the results.

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Abstract

The invention relates to a high performance liquid chromatography detection method for phosphine sodium formate and impurities thereof. According to the method, glacial acetic acid is used for wettingphosphine sodium formate when the test solution and the system applicability solution are prepared, degradation of the impurity D can be effectively reduced, combined detection of the impurity D andthe impurities A, B, C and the like is achieved, the analysis method is greatly simplified, and the analysis efficiency of phosphine sodium formate related substance inspection is improved.

Description

【Technical field】 [0001] The invention relates to the field of drug detection, in particular to a high performance liquid chromatography detection method for sodium foscarnet and its impurities. 【Background technique】 [0002] Foscarnet sodium (Foscarnet sodium, CNa 3 o 5 P·6H 2 O) is a pyrophosphate substance, which can inhibit viral RNA and DNA polymerase, and can also inhibit HIV reverse transcriptase. It is clinically shown to have good curative effect on cytomegalovirus, herpes virus, etc., and is a non-nucleoside antiviral drug with high efficiency, low toxicity and broad spectrum. [0003] Due to the influence of different conditions, foscarnet sodium will produce impurities during production and storage, which will affect the efficacy and safety of the drug. Common impurities include impurity A, impurity B, impurity C and impurity D. Therefore, it is necessary to effectively detect foscarnet sodium and impurities to ensure the efficacy and safety of the drug. T...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 陈明李苗聂小春
Owner 武汉药品医疗器械检验所
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