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Analysis method for tedizolid phosphate related substances

A technology of tedizolid phosphate and related substances, which is applied in the field of medicine, can solve problems such as short time, achieve high precision, high detection efficiency, and control product quality.

Active Publication Date: 2017-06-16
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug has been approved by the FDA for a short period of time and has not yet been approved for import, but the clinical application for imported drugs has been approved and clinical trials are being conducted in China

Method used

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  • Analysis method for tedizolid phosphate related substances
  • Analysis method for tedizolid phosphate related substances
  • Analysis method for tedizolid phosphate related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Liquid chromatography conditions are as follows:

[0077] Chromatographic column: Thermo Hypersil gold, size 4.6×250mm, 5μm;

[0078] Mobile phase A: 0.015mol / L dipotassium hydrogen phosphate, adjusted to pH 6.0 with phosphoric acid;

[0079] Mobile phase B: acetonitrile;

[0080] Detection wavelength: 300nm;

[0081] Flow rate: 1.0ml / min

[0082] Column temperature: 30℃

[0083] The gradient elution procedure is shown in the table below:

[0084]

[0085]

[0086] Step 1, preparation of the test solution: the method is as follows: take 12.5 mg of tedizolid phosphate, add mobile phase A to dissolve and dilute to 25 ml, as the test solution.

[0087] Step 2, the preparation of the reference solution: the method is as follows: take the sample to be tested, the crude product process impurities, the crude product methyl heterotopic impurities, the crude product fluorine-free process impurities, the intermediate impurities, and the final product process impurities...

Embodiment 2

[0090] Liquid chromatography conditions are as follows:

[0091] Chromatographic column: Thermo Hypersil gold, size 4.6×250mm, 5μm;

[0092] Mobile phase A: 0.015mol / L dipotassium hydrogen phosphate, adjusted to pH 6.5 with phosphoric acid;

[0093] Mobile phase B: acetonitrile;

[0094] Detection wavelength: 300nm;

[0095] Flow rate: 0.8ml / min

[0096] Column temperature: 25℃

[0097] The gradient elution procedure is shown in the table below:

[0098] time (min) Mobile phase A (%) Mobile phase B (%) 0 90 10 5 90 10 30 60 40 40 60 40 41 90 10 50 90 10

[0099] Step 1, preparation of the test solution: the method is as follows: take 12.5 mg of tedizolid phosphate, add mobile phase A to dissolve and dilute to 25 ml, as the test solution.

[0100] Step 2, the preparation of the reference solution: the method is as follows: take the sample to be tested, the crude product process impurities, the crude product methyl heter...

Embodiment 3

[0103] Liquid chromatography conditions are as follows:

[0104] Chromatographic column: Thermo Hypersil gold, size 4.6×250mm, 5μm;

[0105] Mobile phase A: 0.015mol / L dipotassium hydrogen phosphate, adjusted to pH 7.0 with phosphoric acid;

[0106] Mobile phase B: acetonitrile;

[0107] Detection wavelength: 300nm;

[0108] Flow rate: 1.2ml / min

[0109] Column temperature: 35℃

[0110] The gradient elution procedure is shown in the table below:

[0111] time (min) Mobile phase A (%) Mobile phase B (%) 0 90 10 5 90 10 30 60 40 40 60 40 41 90 10 50 90 10

[0112] Step 1, preparation of the test solution: the method is as follows: take 12.5 mg of tedizolid phosphate, add mobile phase A to dissolve and dilute to 25 ml, as the test solution.

[0113] Step 2, the preparation of the reference solution: the method is as follows: take the sample to be tested, the crude product process impurities, the crude product methyl heter...

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Abstract

The invention relates to an analysis method for tedizolid phosphate related substances. Timely, effective and accurate analysis and determination on product content and related substances need to be carried out in a bulk drug production process. The analysis method established by the invention is simple and practicable, sensitive, accurate and highly precise, has high detection efficiency on tedizolid phosphate process impurities, can be applied in mass production to control product quality more effectively.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a related substance detection method of tedizolid phosphate. Background technique [0002] Tedizolid phosphate, the structural formula is as follows: [0003] [0004] It is an oxazolidinone antibacterial drug developed for the American Cubist Company (now acquired by Merck & Co.) for the treatment of acute bacterial skin diseases and skin structure infections. The drug was approved by the FDA in June 2014 and was listed in the United States under the trade name SIVEXTRO. It is a 200 mg tablet and a lyophilized powder for injection. Dosage is 200 mg orally or intravenously (1 hour) daily for 6 days. Oxazolidinone antibiotic drugs for the treatment of acute bacterial skin diseases and skin structure infections. [0005] Tedizolid phosphate is a prodrug that can be rapidly converted into biologically active tedizolid by phosphatase in vivo. For use by Staphyloco...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74G01N30/86
Inventor 谷守娜贾薇王桂霞苗玉梅李宝齐郭嘉林孔凯董凯
Owner TIANJIN CHASE SUN PHARM CO LTD
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