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Headspace gas chromatography detection method of residual solvents in macroporous resin extract

A detection method and technology of macroporous resin, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as the detection method of simultaneous determination of residual solvents, etc.

Inactive Publication Date: 2010-10-13
BEIJING UNION PHARMA FACTORY
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Problems solved by technology

[0003] Headspace gas chromatography is a method developed in recent years for the determination of residual solvents in drugs. After reviewing relevant literature, there is no report on the simultaneous determination of the above seven residual solvents.

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  • Headspace gas chromatography detection method of residual solvents in macroporous resin extract
  • Headspace gas chromatography detection method of residual solvents in macroporous resin extract
  • Headspace gas chromatography detection method of residual solvents in macroporous resin extract

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preparation example Construction

[0035] (2) Preparation of the reference substance solution Take another appropriate amount of chromatographically pure ethanol, n-hexane, benzene, toluene, methylcyclohexane, xylene, styrene and divinylbenzene, accurately weigh them respectively, put them into the same measuring bottle, add Dissolve and dilute 50% dimethyl sulfoxide to prepare a homogeneous solution containing 0.8 μg of benzene, 8 μg of n-hexane, toluene, methylcyclohexane, xylene, styrene, divinylbenzene, and 80 μg of ethanol per 1 ml as a control product solution.

[0036] (3) Preparation of the test solution Take an appropriate amount of HP-5, weigh it accurately, add 50% dimethyl sulfoxide to dissolve and dilute to make a uniform solution containing about 400 mg of this product per 1 ml as the test solution.

[0037](4) Determination Accurately measure 1.0ml each of the reference substance solution and the test solution respectively, put them in the headspace bottle, adopt the headspace preheating method, ...

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Abstract

The invention discloses a headspace gas chromatography detection method of residual solvents in a macroporous resin extract, which can be used for simultaneously measuring normal hexane, benzene, methylbenzene, methylcyclohexane, dimethylbenzene, styrene and divinylbenzene in the macroporous resin extract. The method comprises the following steps of: (1) carrying out tests of chromatographic conditions and system suitability; (2) preparing a comparison product solution; (3) preparing a test product solution; and (4) measuring. The specificity, the system suitability, the linearity, the precision, the minimum detection limit, the recovery rate, and the like of the method all meet the requirements of drug quality standard analysis method verification and guiding principles in the first appendix of the Chinese pharmacopoeia (Version 2005).

Description

technical field [0001] The invention relates to a method for determining residual solvents in macroporous resin extracts, which is characterized in that n-hexane, benzene, toluene, methylcyclohexane, xylene, styrene and diethylene are simultaneously determined by headspace gas chromatography. benzene. Background technique [0002] The macroporous resin extraction method is currently widely used in the purification and extraction process of Chinese herbal medicines, and its extracts are mainly used as raw materials for health care products and pharmaceutical production. Because macroporous resins are prone to residues of toxic solvents such as n-hexane, benzene, toluene, methylcyclohexane, xylene, styrene and divinylbenzene during production and storage. In order to ensure the safety and effectiveness of drugs, the State Food and Drug Administration requires the inspection of residual solvents for products extracted with macroporous resins. At the same time, according to the...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/30G01N30/68
Inventor 赵立敏刘冬杨敬芝张东明
Owner BEIJING UNION PHARMA FACTORY
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