Method for detecting related substance II of cefpirome in cefpirome sulfate/sodium chloride injection

Abstract

The invention provides a method for detecting a related substance II of cefpirome in cefpirome sulfate / sodium chloride injection. According to the method, experiments on chromatographic conditions and system suitability are performed by using high-performance liquid chromatography. For the color spectrum which is suitable for separating globular protein of which the molecular weight is 1,000-5,000, hydrophilic silica gel serves as a filler, and phosphate buffer solution-acetonitrile of which the volume ratio is 85:15 serves as a mobile phase, wherein the flow velocity is 0.5 ml / min, the phosphate buffer solution consists of 0.05 mol / L disodium hydrogen phosphate and 0.05 mol / L sodium dihydrogen phosphate which are mixed in the volume ratio of 50:50, and the measurement wavelength is 254 nm. The method comprises the following steps of: placing appropriate amount of cefpirome sulfate / sodium carbonate mixed powder which comprises 10 mg of cefpirome into a 10 ml measuring flask, wherein the mixed powder is taken out of an infusion bag; adding water to dissolve the mixed powder and diluting to certain scale, and shaking up; and injecting 20 mu l of the diluted solution into a liquid chromatograph to perform chromatography, and recording a chromatogram. The detection method is advanced, reliable, high in accuracy and high in specificity, the experimental apparatus is high in precision, high in reproducibility and high in stability, the related substance II of the cefpirome can be effectively detected, and the method can be used for quality control.

Description

technical field [0001] The invention belongs to the field of medicine quality detection, and specifically relates to a method for detecting cefpirome-related substance II in cefpirome sulfate / sodium chloride injection non-PVC ready-to-mix infusion. Background technique [0002] At present, the patent document Patent No. 200520115059 discloses a cefpirome sulfate double-chamber infusion bag packaging, but there is no relevant detection method recorded in the instructions. [0003] Moreover, the State Food and Drug Administration of China promulgated the Cefpirome Sulfate / Sodium Chloride Injection Standard (Trial Implementation) (YBH17062005), which is also the non-PVC i.e. The standard of reference for the detection of matching infusion. [0004] Among them, the related substance II (polymer) of cefpirome is a very important and indispensable testing item for infusion dosage forms, and it is also an important subject of research by many research and development institutions....

AI Technical Summary

Problems solved by technology

[0006] The shortcoming of described assay method is: G-10 chromatographic column sensitivity is low, and resolution is poor, can not reach baseline separation, and sampling time is too long, can't detect cefpirome polymer accurately, can't reach detection purpose, can't provide correct, accurate, Reliable detection methods cannot provide guidance methods for ensuring product quality