Method for simultaneously quantitative detecting erucyl amide and ethylene bis stearamide

Abstract

The invention provides a method for simultaneously quantitative detecting erucyl amide and ethylene bis stearamide. The method comprises the following steps: cutting a drug packaging material sample into pieces, soaking into an extraction medium, placing in a closed container and extracting, thereby acquiring an extracting solution; precisely weighting the extracting solution, adding a mixed solvent and an internal standard stock solution, shaking and standing by till layering; removing a solution on the upper layer, and then adding the mixed solvent, shaking, standing by till layering and taking the solution on the bottom layer; injecting the sample into a gas chromatograph, performing gas chromatography and respectively calculating peak areas, thereby acquiring respective contents of erucyl amide and ethylene bis stearamide. The method for simultaneously quantitative detecting erucyl amide and ethylene bis stearamide has the advantage of simple, quick and convenient operation and hashigher sensitivity and strong specificity, so that the method is particularly suitable for the detection in drug packaging material and drug compatibility research and the analysis for migrated amount of erucyl amide and ethylene bis stearamide, and the method has a wide application prospect.

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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