Method for detecting impurities in cefoxitin product

A cefoxitin and detection head technology, applied in the field of detection of impurities in cefoxitin products, can solve the problems of inability to distinguish four impurities, quantitative research, etc., and achieve the effects of reducing adverse reactions, effective quality, and strong specificity

Active Publication Date: 2009-10-14
HAIKOU PHARMA FACTORY
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  • Claims
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Problems solved by technology

Most of the existing detection methods use the self-control method to determine the related substances, and only measure the content of a single impurity or the total impurities, but cannot distinguish the four impurities in the product at the same time and conduct quantitative research separately

Method used

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  • Method for detecting impurities in cefoxitin product
  • Method for detecting impurities in cefoxitin product
  • Method for detecting impurities in cefoxitin product

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Embodiment 1

[0025] Reversed-phase high-performance liquid chromatography is used to carry out gradient elution through mixed solvents of different polarities, and the absorption peak of impurities is measured at ultraviolet 254nm, and the content of impurities is calculated by using known impurity reference substances.

[0026] (1) Chromatographic conditions:

[0027] Chromatographic column: YWG-C12H25 column (manufactured by Tianjin Second Reagent Factory);

[0028] Instrument: Shimadzu 10A high performance liquid chromatograph: LC-10AT solvent delivery pump, SPD-10AV ultraviolet detector, Zhejiang University 2010 chromatographic workstation;

[0029] Reagents: acetonitrile (chromatographically pure), potassium dihydrogen phosphate (A.R.), phosphoric acid (A.R.);

[0030] Mobile phase A: 0.7% (weight / volume) dipotassium hydrogen phosphate solution, adjusted to pH 3.5 with phosphoric acid;

[0031] Mobile phase B: acetonitrile;

[0032] Elute according to the gradient listed in the tab...

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Abstract

The invention provides a method for detecting impurities in a cefoxitin product. The method adopts high performance liquid chromatography and comprises the steps that an inverted octadecylsilyl bonded phase silica gel chromatographic column is adopted; 0.7 percent (weight / volume) of dipotassium hydrogen phosphate aqueous solution with a pH of 3.5 adjusted by phosphoric acid serves as a mobile phase A and acetonitrile as a mobile phase B; the mobile phase A and the mobile phase B are combined into a mixed mobile phase which goes through gradient elution under the following conditions: during 0 to 5 minutes, the volume ratio of the mobile phase A and the mobile phase B is 95:5; during 5 to 15 minutes, the volume ratio of the mobile phase A and the mobile phase B is uniformly changed from 95:5 to 70:30; during 15 to 35 minutes, the volume ratio of the mobile phase A and the mobile phase B is uniformly changed from 70:30 to 30:70; during 35 to 45 minutes, the volume ratio of the mobile phase A and the mobile phase B is uniformly changed from 30:70 to 15:85; and during 45 to 60 minutes, the volume ratio of the mobile phase A and the mobile phase B is uniformly changed from 15:85 to 95:5. The method can be used for respectively conducting quantitative detection on four impurities in cefoxitin, which is simple and convenient and has strong specificity.

Description

technical field [0001] The invention relates to a method for detecting impurities in cefoxitin products, in particular to a method for detecting impurities in cefoxitin products by using high performance liquid chromatography. Background technique [0002] Cefoxitin belongs to the second-generation cephalosporins. It is a semi-synthetic broad-spectrum bactericidal drug derived from chemical modification of cephamycin C. Its bactericidal effect stems from the ability to inhibit the synthesis of bacterial cell walls. Compared with the first-generation cephalosporins, the effect of cefoxitin on most Gram-negative bacteria resistant to the first-generation cephalosporins is significantly enhanced, and it is highly effective against anaerobic bacteria; it is more stable to various β-lactamases ; The toxicity to the kidneys is also reduced. Cefoxitin has a unique chemical structure (see the structure shown in formula I), and the methoxy group in its structure is in the "trans" fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/36G01N30/74C07D501/57
Inventor 张志兰曾袆华李捷
Owner HAIKOU PHARMA FACTORY
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