A method for the simultaneous quantitative detection of erucamide and ethylene bisstearamide

Abstract

The invention provides a method for quantitatively detecting erucamide and ethylene bisstearamide at the same time, comprising the following steps: cutting a sample of a pharmaceutical packaging material, immersing it in an extraction medium, and placing it in a closed container for extraction to obtain an extraction solution; accurately weigh the extraction solution, add the mixed solvent and the internal standard stock solution, shake it, and let it stand to separate layers; after removing the upper layer solution, add the mixed solvent again, shake it, stand it until it separates, and remove the lower Solution; sample injection to gas chromatograph, carry out gas chromatographic analysis, calculate peak area respectively, obtain the respective content of erucamide and ethylene bisstearamide. The method for simultaneous quantitative detection of erucamide and ethylene bisstearamide shows the advantages of simple and quick operation, higher sensitivity and strong specificity; therefore, it is particularly suitable for use in pharmaceutical packaging materials and pharmaceutical compatible It can be used to detect and analyze the migration of the two in sex research, so it has broad application prospects.

Description

technical field [0001] The invention relates to the technical field of instrumental analysis, in particular to a method for quantitatively detecting erucamide and ethylene bisstearamide simultaneously. Background technique [0002] As we all know, erucamide (CAS No.: 112-84-5) and ethylene bisstearamide (CAS No.: 110-30-5) are mainly used as anti-adhesive and slippery agents for various plastics and resins. Can be used as an excellent lubricant and antistatic agent for extruded films. According to current reports, erucamide and ethylene bisstearamide are non-toxic in themselves, but when they are used in pharmaceutical packaging materials, if they migrate into pharmaceutical preparations, the impact on the stability of the preparation is unknown, so In the study of drug packaging materials and drug compatibility, it is still necessary to investigate and analyze its migration. [0003] However, common analytical methods in the prior art often have the following problems whe...

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Problems solved by technology

According to current reports, erucamide and ethylene bisstearamide are non-toxic in themselves, but when they are used in pharmaceutical packaging materials, if they migrate into pharmaceutical preparations, the impact on the stability of the preparation is unknown, so In the study of drug packaging materials and drug compatibility, it is still necessary to investigate and analyze its migration amount

[0003] However, common analytical methods in the prior art often have the following problems when applied to the determination of the mobility of erucamide and ethylene bisstearamide: a. due to the absence of large conjugated structures in the two structures, the ultraviolet absorption signal The response is low, so the sensitivity is low when measured by high performance liquid chromatography; b. When using pre-column derivatization-gas chromatography, since the derivatization reaction requires anhydrous, but the extraction medium is mostly an aqueous medium, it is necessary to implement harsh The water removal step leads to cumbersome operation; c. when using infrared spectroscopy to measure, the specificity is poor and the error is large; d. the chemical method reported in the literature can measure the content of a series of fatty acid amides, but its specificity is poor and cannot be used for certain Quantitative analysis of a specific class of fatty acid amides

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