Method for detecting polymer in cefoxitin sodium for injection

A technique for detecting cefoxitin sodium and its detection method, which is applied in the detection field of polymers in cefoxitin sodium for injection, and can solve problems such as turbidity, light and thermal instability, and poor stability

Pending Publication Date: 2021-08-20
SHENYANG SANJIU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] Clinically, cefoxitin sodium is mostly made into intravenous and intramuscular injection preparations. This preparation has poor stability, is very unstable to light and heat, and th...

Method used

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  • Method for detecting polymer in cefoxitin sodium for injection
  • Method for detecting polymer in cefoxitin sodium for injection
  • Method for detecting polymer in cefoxitin sodium for injection

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Experimental program
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Embodiment 1

[0034] Establishment of a detection method for polymers in cefoxitin sodium for injection.

[0035] 1. Column selection

[0036] Coagulation chromatographic columns are often used for traditional polymer detection, but the method of the present invention uses phenylsilane-bonded silica gel as a filler.

[0037] 2. Mobile phase selection.

[0038] The ammonium acetate solution that can enter the mass spectrometer is selected as the water phase and the pH value is adjusted to 6.0-8.0.

[0039] 3. Selection of elution program

[0040] Extract the molecular weight of the eluted impurities by mass spectrometry, adjust the proportion of the organic phase, and confirm the final elution procedure to ensure that the polymer can be effectively eluted.

[0041] 4. Concentration selection of the test substance

[0042] Increase the concentration of the test product to 5 mg / ml, so that the chromatographic peaks eluted in the test product solution can obtain effective mass spectrum info...

Embodiment 2

[0075] Detection of polymers in cefoxitin sodium for injection.

[0076] Six batches of samples were tested for polymer according to the polymer detection method provided by the present invention, and the test results are shown in Table 7 below.

[0077] The detection method of cefoxitin sodium polymer for injection comprises the following steps.

[0078] 1. Chromatographic conditions

[0079] High performance liquid chromatography.

[0080] Chromatographic column: use phenylsilane bonded silica gel as filler;

[0081] Mobile phase: mobile phase A: 1.2 g / L ammonium ammonium acetate solution, adjust the pH value to 7.0 with ammonia water; mobile phase B: acetonitrile Mobile phase elution program is shown in Table 6.

[0082] Table 6 Mobile phase elution program.

[0083] time (min) Mobile phase A(%) Mobile phase B(%) 0 92 8 5 92 8 50 74 26 51 50 50 58 50 50 59 92 8 70 92 8

[0084] Injection volume: 20 μL; flow ra...

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Abstract

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for detecting polymers in cefoxitin sodium for injection. The method comprises three steps of detection condition, solution preparation, system applicability requirement and limit. According to the present invention, the high performance liquid chromatography is adopted, such that the operation is simple, the sensitivity is high, the specificity is good, the content of the single polymer and the total polymer in the product can be accurately controlled, the product quality can be effectively controlled, and the clinical use safety can be ensured.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for detecting polymers in cefoxitin sodium for injection. Background technique [0002] Cefoxitin sodium is a cephamycin antibiotic developed by Merck Sharp & Dohme Company of the United States and listed in 1974. It is a new type of antibiotic produced by semi-synthesis of cephalosporin C (cephamycin C) produced by streptomycin , whose mother nucleus is similar to cephalosporins and has similar antibacterial properties, it is customarily included in the second-generation cephalosporins. The chemical name of Cefoxitin Sodium is: (6R,7S)-3-(carbamoyloxymethyl)-7-methoxy-8-oxo-7-[2(2-thienyl) Acetylamino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. Its chemical structural formula is: [0003] [0004] Cefoxitin Sodium is a brand-new cephalosporin antibiotic drug developed by Merck & Co. of the United States, which was introduced into the ...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 步显坤史清华李阳王惠琳鄂一丹相宇
Owner SHENYANG SANJIU PHARMA
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