LC-MS (liquid chromatography-mass spectrometry) method used for screening antioxidant in elastomer seal of drug packaging

Abstract

The invention belongs to the technical field of analytical chemistry and discloses an LC-MS (liquid chromatography-mass spectrometry) method used for screening an antioxidant in an elastomer seal of adrug packaging. The method comprises the following steps: breaking a to-be-detected elastomer into particles with the size of 5mm*5mm, weighing 0.5g of a broken rubber plug, loading the broken rubberplug into a microwave digestion tube, adding 10ml of dichloromethane into the microwave digestion tube for swelling overnight, performing microwave digestion at the temperature of 40 DEG C for 45minand cooling to room temperature; filtering with a glass hopper, removing the elastomer particles, performing vacuum rotary evaporation on filtrate, removing a dichloromethane solvent, dissolving residues with 8ml of methanol through ultrasonic oscillation after evaporation, transferring dissolved solution into a 10ml of measuring flask and enabling the volume of the dissolved solution to be constant with methanol; taking the solution after the volume of the dissolved solution is constant, filtering the solution with a 0.45mum of nylon filtering membrane and detecting filtrate with an LC method. The LC-MS method has the advantages of being high in accuracy, good in sensitivity, short in detection time and strong in qualitative and quantitative accuracy; the LC-MS method is strong in tolerance to a matrix, the coverage of the antioxidant is comprehensive, and degradation products of the antioxidant are monitored meanwhile.

Description

technical field [0001] The invention belongs to the technical field of analytical chemistry, and in particular relates to a liquid mass spectrometry method for screening antioxidants in elastic body seals of drug packaging. Background technique [0002] As a packaging component, on the one hand, the seal should meet the sealing requirements of the packaging system, provide protection for the drug and meet the expected use function of the package; on the other hand, it should have good compatibility with the drug, that is, it should not be introduced into a Risky extracts, or the level of extracts meet the safety requirements; and the quality, efficacy and safety of the drug will not be affected by the adsorption of active ingredients or functional excipients in the drug. Antioxidants, as a routinely added additive in elastomers, have the risk of migrating into drugs during the packaging, storage and transportation of drugs, so in the process of drug quality control, especial...

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Problems solved by technology

[0004] (1) The sample preparation process usually uses toluene reflux, which is relatively time-consuming, wastes materials, and causes great environmental pollution.

[0005] (2) The types of detection targets are limited to one or two specific antioxidant targets, but there are many types and numbers of antioxidants actually added to the elastomer. If the traditional method is used, it is necessary to inject multiple targets separately. And multiple tests are required to complete the qualitative screening and quantitative analysis of potential extractables, lack of system and low screening efficiency

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