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Method for testing content of tedizolid phosphate enantiomer through high performance liquid chromatography

A technology of tedizolid phosphate and high performance liquid chromatography, applied in the field of medicine, can solve problems such as complicated operation

Active Publication Date: 2018-01-23
成都美域高制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But this method is too complex to operate

Method used

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  • Method for testing content of tedizolid phosphate enantiomer through high performance liquid chromatography
  • Method for testing content of tedizolid phosphate enantiomer through high performance liquid chromatography
  • Method for testing content of tedizolid phosphate enantiomer through high performance liquid chromatography

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Experimental program
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Effect test

Embodiment 1

[0051] Embodiment 1 high performance liquid chromatographic method is measured tedizolid phosphate enantiomer content

[0052] 1. Main technical parameters of high performance liquid chromatography

[0053] a. High performance liquid chromatography;

[0054] B, silica gel surface covalently bonded -O-9-(tert-butylcarbamoyl) quinine is a chiral chromatographic column with a stationary phase;

[0055] c, mobile phase: methyl alcohol: acetonitrile: acetic acid: ammonium acetate=50: 50: 3: 0.8, flow velocity is 1.0ml / min;

[0056] d. The detection wavelength is 300nm, and the column temperature is 30°C.

[0057] 2. Determination method

[0058] (1) Configuration solution

[0059] a. Precisely weigh 51.35mg of tedizolid phosphate (batch number 20170301, provided by Chengdu Weibang Pharmaceutical Co., Ltd.) into a 50ml volumetric flask, dilute to the mark with mobile phase, and use it as solution A.

[0060] b. Accurately weigh 21.2 mg of the enantiomer of tedizolid phosphate, pl...

Embodiment 2

[0080] Embodiment 2 Determination of tedizolid phosphate enantiomer content by high performance liquid chromatography

[0081] 1. Main technical parameters of high performance liquid chromatography

[0082] a. High performance liquid chromatography;

[0083] B, silica gel surface covalently bonded -O-9-(tert-butylcarbamoyl) quinine is a chiral chromatographic column with a stationary phase;

[0084] c. Mobile phase: methanol: acetonitrile: acetic acid: ammonium acetate=50:50:2:0.5, the flow rate is 1.2ml / min;

[0085] d. The detection wavelength is 300nm, and the column temperature is 35°C.

[0086] 2. Determination method

[0087] (1) Configuration solution

[0088] a. Precisely weigh 50.80 mg of tedizolid phosphate (batch number 20170305, provided by Chengdu Weibang Pharmaceutical Co., Ltd.) into a 50 ml volumetric flask, dilute to the mark with mobile phase, and use it as solution A.

[0089] b. Accurately weigh 22.0 mg of tedizolid phosphate enantiomer, place it in a ...

Embodiment 3

[0107] Embodiment 3 Determination of tedizolid phosphate enantiomer content by high performance liquid chromatography

[0108] (1) Main technical parameters of high performance liquid chromatography

[0109] a. High performance liquid chromatography;

[0110] B, silica gel surface covalently bonded -O-9-(tert-butylcarbamoyl) quinine is a chiral chromatographic column with a stationary phase;

[0111] c, mobile phase: methyl alcohol: acetonitrile: acetic acid: ammonium acetate=50: 50: 3: 0.8, flow velocity is 1.0ml / min;

[0112] d. The detection wavelength is 300nm, and the column temperature is 30°C.

[0113] (2) Determination method

[0114] a. The test solution: Precisely measure tedizolid phosphate and place it in a volumetric flask, dilute to the mark with the mobile phase, and make a solution of about 0.514 mg / ml as the test solution.

[0115] b. Control solution: Accurately measure 1.0ml of the test solution into a 100ml volumetric flask, dilute to the mark with mobi...

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Abstract

The invention discloses a method for testing the content of tedizolid phosphate enantiomer through high performance liquid chromatography. The method comprises the following steps: (1) preparing a test solution, namely precisely weighing tedizolid phosphate, diluting with a mobile phase, and uniformly shaking so as to obtain the test solution; (2) preparing a control solution, namely precisely weighing the test solution, diluting with the mobile phase, and uniformly shaking so as to obtain the control solution; (3) testing the content, namely respectively injecting the control solution and thetest solution into a liquid chromatography meter, recording spectrums, and calculating the content of the tedizolid phosphate enantiomer by using a self-contrasted method, wherein the mobile phase ismethanol-acetonitrile-acetic acid-ammonium acetate. By selecting spectrum conditions, tedizolid phosphate and enantiomer impurities of the tedizolid phosphate can be simply, rapidly and accurately separated and detected, and controllable quality of tedizolid phosphate and a preparation of the tedizolid phosphate is achieved. Development of synthesis processes is instructed, and quality standard formulation of tedizolid phosphate raw material medicines can be facilitated.

Description

technical field [0001] The invention relates to a method for measuring the content of tedizolid phosphate enantiomers by high performance liquid chromatography, and belongs to the technical field of medicine. Background technique [0002] Tedizolid Phosphate is a new type of oxazolidinone antibiotic developed by Cubist Pharmaceuticals. Its chemical name is {(5R)-(3-{3-fluoro-4-[6-(2-methyl-2H- Tetrazol-5-yl)-pyridin-3-yl]phenyl}-2-oxooxazolidin-5-yl)}methyl phosphate. Approved by the FDA in 2014, it is clinically used to treat acute bacterial skin and skin structure infections. Tedizolid phosphate is a prodrug that can be rapidly converted into biologically active tedizolid by phosphatase in vivo, thereby inhibiting protein synthesis. Its mechanism of action is different from other antibiotics, and cross-resistance will not occur with other antibiotics. Clinically, it is mainly used for the treatment of acute bacterial skin and skin structures caused by Staphylococcus aur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 随裕敏王继英陈睿宇
Owner 成都美域高制药有限公司
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