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Method for detecting peramivir trihydrate by reversed-phase high performance liquid chromatography

A technology of peramivir trihydrate and reversed-phase high-performance liquid phase, which can be applied to measurement devices, instruments, scientific instruments, etc., can solve the difficulty of mobile phase pH screening, affect the quality of peramivir, drug safety, and quality differences bigger problems

Active Publication Date: 2021-05-07
JIANGSU LONG HEALTHCARE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there are many manufacturers supplying peramivir in the market, and the quality varies greatly. There are some impurity compounds. The existence of some impurities will seriously affect the quality and drug safety of peramivir, so it needs to be tested and quality controlled
Due to the solubility of peramivir and the presence of multiple pKa, it is difficult to screen the pH of the mobile phase

Method used

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  • Method for detecting peramivir trihydrate by reversed-phase high performance liquid chromatography
  • Method for detecting peramivir trihydrate by reversed-phase high performance liquid chromatography
  • Method for detecting peramivir trihydrate by reversed-phase high performance liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1: Specificity test

[0034] Solvent: mobile phase A-mobile phase B=92:8 (V:V)

[0035] Impurity 1 mother liquor: Weigh 6 mg of Impurity 1 reference substance, accurately weigh it, put it in a 10mL volumetric flask, add solvent to dissolve and dilute to the mark, shake well, and prepare a solution with a concentration of Impurity 1 reference substance of 0.6 mg / mL.

[0036] Impurity 2 mother liquor: Weigh 6 mg of Impurity 2 reference substance, accurately weigh it, put it in a 10 mL volumetric flask, add solvent to dissolve and dilute to the mark, shake well, and prepare a solution with a concentration of Impurity 2 reference substance of 0.6 mg / mL.

[0037] Impurity 3 mother liquor: Weigh 6 mg of Impurity 3 reference substance, accurately weigh it, put it in a 10 mL volumetric flask, dissolve it with a solvent, dilute to the mark, shake well, and prepare a solution with a concentration of Impurity 3 reference substance of 0.6 mg / mL.

[0038] Peramivir mother s...

Embodiment 2

[0051] Example 2: Sensitivity test

[0052] Impurity Quantitative Limit Solution: Take Impurity 1, Impurity 2, and Impurity 3 under the specificity item, put them in different 50mL volumetric flasks, add solvent to dilute to the mark, shake well, and then precisely measure 3mL separately and place them in the same 100mL volumetric flask , dilute to the mark with solvent, and shake well. Then precisely measure 3mL of this solution and put it in a 5mL volumetric flask, add solvent and dilute to the mark.

[0053] Impurity detection limit solution: Precisely measure 3mL of the limit of quantification solution, put it in a 10mL volumetric flask, add solvent to dilute to the mark.

[0054] Peramivir limit of quantitation solution: Weigh 16 mg of peramivir reference substance, accurately weigh it, put it in a 20 mL volumetric flask, add solvent to dissolve and dilute to the mark, and shake well. Precisely measure 1mL, put it in a 50mL measuring bottle, add solvent to dilute to the...

Embodiment 3

[0060] Example 3: Linearity test

[0061] Dilute peramivir and its impurity reference substance solution with diluent to prepare a series of concentration reference solutions, inject into liquid chromatograph, and record the chromatogram. The results are shown in Tables 3-6.

[0062] Table 7 Impurity 1 standard curve

[0063]

[0064]

[0065] Table 8 Impurity 2 Linearity

[0066]

[0067]

[0068] Table 9 Impurity 3 Linearity

[0069]

[0070] Table 10 Peramivir linearity

[0071]

[0072]

[0073] It can be seen from Tables 7-10 that within the range of 0.2-3 μg / ml, the detection method of the present invention has a good linear relationship.

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Abstract

The invention discloses a method for detecting peramivir by reversed-phase high performance liquid chromatography. The method comprises the following steps: preparing a test sample solution, detecting a test sample by reversed-phase high performance liquid chromatography, and calculating the contents of single impurity and total impurity in the test sample according to an area normalization method. According to the method, chromatographic peaks of peramivir and impurities are completely separated by changing a mobile phase, a ratio, the wavelength of an ultraviolet absorption detector and the like; and the method has the advantages of high specificity, accuracy and sensitivity, short peak appearance time, short detection time, accurate and stable detection result, simple detection method and favorable linear relationship, and can perform more accurate detection and quality control on peramivir.

Description

technical field [0001] The invention relates to an analysis method of peramivir, in particular to a reversed-phase high performance liquid chromatography analysis method of peramivir trihydrate. Background technique [0002] Peramivir is a novel cyclopentane anti-influenza virus drug, which is another novel influenza virus NA inhibitor after Zanamivir and Oseltamivir were successfully developed and launched in 1999. agent. On April 5, 2013, the State Food and Drug Administration approved the new anti-influenza drug Peramivir Sodium Chloride Injection, and the existing clinical trial data proved that it is effective against influenza A and B. [0003] The synthetic product of peramivir is (1S,2S,3R,4R)-3-((S)-1-acetamide-2-ethylbutyl)-4-guanidine-2-hydroxycyclopentane-1- Carboxylic acid, molecular formula C 15 H 28 N 4 O 4 ·3H 2 O, the molecular weight is 382.46, and the structural formula is as follows: [0004] [0005] At present, there are many manufacturers su...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N30/8679
Inventor 郭辉赵佳楠高文静李娜
Owner JIANGSU LONG HEALTHCARE
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