Method for detecting polymer impurities of ceftriaxone sodium

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...

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