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Method for detecting polymer impurities of ceftriaxone sodium

A ceftriaxone sodium and detection method technology, which is applied in the detection field of ceftriaxone sodium polymer impurities, can solve the problems of poor specificity, poor peak shape, low number of theoretical plates, etc., and achieve good specificity effect

Pending Publication Date: 2021-05-14
BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The method used in the Chinese Pharmacopoeia for the determination of polymers uses dextran gel G-10 as a filler. This method has poor specificity, and the number of theoretical plates is low and the peak shape is poor.

Method used

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  • Method for detecting polymer impurities of ceftriaxone sodium
  • Method for detecting polymer impurities of ceftriaxone sodium
  • Method for detecting polymer impurities of ceftriaxone sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0037] 1. Solution configuration

[0038] Need testing solution: get ceftriaxone sodium crude drug, accurately weighed, add water to dissolve and quantitatively dilute and make the solution that contains ceftriaxone 0.5mg in every 1mL about, as need testing solution.

[0039] Reference substance solution: take an appropriate amount of ceftriaxone sodium reference substance, accurately weighed, add water to dissolve and quantitatively dilute to make a solution containing about 5 μg per 1 mL as the reference substance solution.

[0040] 2. Chromatographic conditions

[0041] Chromatographic column: TSKgel G2000SWXL 7.8×300mm, 5μm;

[0042] Mobile phase A: 0.14% triethylamine solution, adjust the pH value to 6.0 with phosphoric acid solution;

[0043] Mobile phase B: acetonitrile;

[0044] Mobile phase A:B=95:5;

[0045] Column temperature: 30°C;

[0046] Detection wavelength: 254nm;

[0047] Flow rate: 0.8mL / min.

[0048] 3. Sample determination

[0049] Get 20 μl of nee...

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Abstract

The invention belongs to the technical field of drug detection, and particularly relates to a method for detecting polymer impurities of ceftriaxone sodium. According to the method, a ceftriaxone sodium raw material medicine is taken to prepare a test solution, HPLC detection is carried out, and the detection conditions are as follows: a chromatographic column with globular protein hydrophilic modified silica gel as a filler is adopted as a stationary phase; and the mobile phase is a mixed solution composed of a mobile phase A and a mobile phase B in a volume ratio of (93-97): (7-3), the mobile phase A is a 0.1-0.2% triethylamine solution, the pH value is adjusted to 5.5-6.5 by using a phosphoric acid solution, and the mobile phase B is acetonitrile. The method for detecting the polymer impurities in the ceftriaxone sodium is high in specificity, good in operability and good in accuracy and precision.

Description

technical field [0001] The invention belongs to the technical field of drug detection, and in particular relates to a detection method for ceftriaxone sodium polymer impurities. Background technique [0002] Ceftriaxone sodium is a long-acting, broad-spectrum semi-synthetic cephalosporin drug, synthesized by Roche in 1978, listed in Switzerland for the first time in 1982, and approved by the US FDA in 1984. Use in bulk. At present, the dosage form of ceftriaxone sodium is sterile powder for injection, and there are varieties on the market in Britain, Switzerland and Japan. [0003] The sensitization of ceftriaxone sodium has a certain relationship with the impurity content of its polymer. The polymer of ceftriaxone sodium includes 7-ACA dimer, 7-ACA trimer, deacetylated cefotaxime dimer, 7-ACT dimer and 7-ACT trimer etc. Ceftriaxone sodium molecules are easy to degrade under high temperature conditions to produce polymers, and the control of polymer content is very import...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/32G01N30/34G01N30/36G01N30/54G01N30/74
CPCG01N30/02G01N30/32G01N30/34G01N30/36G01N30/54G01N30/74G01N2030/324
Inventor 宋更申安百锋朱琳琳
Owner BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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