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A detection method of antioxidant dl-alpha-tocopherol and its interfering substances in ointment

A detection method and technology of tocopherol, which is applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of cumbersome ointment operation, no DL-α-tocopherol, etc., simplify the extraction operation method, and facilitate long-term stability Storage and quality monitoring to ensure the effect of quality control

Active Publication Date: 2020-10-02
上海正大通用药业股份有限公司
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  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] In the existing technology, there is no analytical method specifically for the detection of DL-α-tocopherol content in ointment, and the existing reference methods fail to achieve good liquid phase peak shape and good separation, and fail to take into account the ointment at the same time The cumbersome operation of extraction

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  • A detection method of antioxidant dl-alpha-tocopherol and its interfering substances in ointment
  • A detection method of antioxidant dl-alpha-tocopherol and its interfering substances in ointment
  • A detection method of antioxidant dl-alpha-tocopherol and its interfering substances in ointment

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Experimental program
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Effect test

Embodiment 1

[0062] 1. Sample pretreatment

[0063] Preparation of the test solution: Weigh the ointment sample, add n-hexane, heat and dissolve in a water bath at 50-70°C for 1-15min, wherein the ratio of the mass (g) added to the ointment to the volume (ml) added by n-hexane is 1:7~1:8. Cool to room temperature, dilute to volume with n-hexane, shake well, filter, and take the filtrate as the test solution. Filtration is 0.45 μm membrane filtration.

[0064] Preparation of reference solution: Weigh DL-α-tocopherol reference substance, add n-hexane to dissolve and constant volume, prepare DL-α-tocopherol stock solution, DL-α-tocopherol stock solution, DL-α-tocopherol The concentration of phenol was 12-24 μg / mL. Weigh the BHT reference substance, add n-hexane to dissolve and constant volume, and prepare the BHT reference stock solution. In the BHT reference stock solution, the concentration of BHT is 120-240 μg / mL. Weigh DL-α-tocopheryl acetate reference substance, add n-hexane to disso...

Embodiment 2

[0076] 1. Sample pretreatment

[0077] The preparation of need testing solution: take by weighing ointment sample 3g, put in 25mL brown measuring bottle, add 21mL n-hexane, heat and dissolve 1min in 60 ℃ of water baths, wherein, the quality (g) that ointment adds and the volume that n-hexane adds ( ml) ratio of 1:7. Cool to room temperature, dilute with n-hexane to a constant volume of 25ml, shake well, filter with a 0.45μm filter membrane, and take the subsequent filtrate as the test solution.

[0078] Preparation of reference solution: Weigh DL-α-tocopherol reference substance, add n-hexane to dissolve and constant volume, prepare DL-α-tocopherol stock solution, DL-α-tocopherol stock solution, DL-α-tocopherol The concentration of phenol was 12 μg / mL. Weigh the BHT reference substance, add n-hexane to dissolve and constant volume, and prepare the BHT reference stock solution. In the BHT reference stock solution, the concentration of BHT is 120 μg / mL. Weigh DL-α-tocopheryl ...

Embodiment 3

[0090] 1. Sample pretreatment

[0091] The preparation of need testing solution: take by weighing ointment sample 3g, put in 25mL brown measuring bottle, add 21mL n-hexane, heat and dissolve 1min in 60 ℃ of water baths, wherein, the quality (g) that ointment adds and the volume that n-hexane adds ( ml) ratio of 1:7. Cool to room temperature, dilute with n-hexane to a constant volume of 25ml, shake well, filter with a 0.45μm filter membrane, and take the subsequent filtrate as the test solution.

[0092] Preparation of reference solution: Weigh DL-α-tocopherol reference substance, add n-hexane to dissolve and constant volume, prepare DL-α-tocopherol stock solution, DL-α-tocopherol stock solution, DL-α-tocopherol The concentration of phenol was 12 μg / mL. Weigh the BHT reference substance, add n-hexane to dissolve and constant volume, and prepare the BHT reference stock solution. In the BHT reference stock solution, the concentration of BHT is 120 μg / mL. Weigh DL-α-tocopheryl ...

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Abstract

The invention provides a method for detecting antioxidant DL-alpha-tocopherol and interferent thereof in unguent. The method comprises the following steps: 1) preparing a test sample solution; 2) preparing a control product solution; and 3) performing detection. According to the method for detecting the antioxidant DL-alpha-tocopherol and the interferent thereof in the unguent, a pretreatment andHPLC detection method with optimal conditions is adopted, a target peak and an interferent peak can be effectively separated, the content of the antioxidant DL-alpha-tocopherol and interferent thereofin the unguent can be measured accurately, and the antioxidant DL-alpha-tocopherol and interferent thereof in the unguent can be controlled, so that the quality of the unguent is guaranteed.

Description

technical field [0001] The invention belongs to the technical field of analysis and detection of pharmaceutical components, and relates to a method for detecting the antioxidant DL-α-tocopherol and its interfering substances in ointment, in particular to a method for analyzing and determining calcitriol in ointment by using high performance liquid chromatography. Antioxidant DL-α-tocopherol and its interferer 2,6-di-tert-butyl-4-methylphenol (BHT), DL-α-tocopherol acetate. Background technique [0002] DL-α-tocopherol, the chemical name is (±)-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-color Alcohol, also known as vitamin E alcohol, is a class of compounds that mainly exhibit vitamin E activity. It was named "tocopherol" because its vitamin activity was first identified in 1936 in experiments on fertility factors in rats. It exists in edible oils, fruits, vegetables and grains. It is a fat-soluble vitamin and an important antioxidant. The congeners of DL-α-toco...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88G01N30/06G01N30/34
CPCG01N30/06G01N30/34G01N30/88G01N2030/047G01N2030/884
Inventor 马媛媛任寅顾兆姝徐子平
Owner 上海正大通用药业股份有限公司
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