CN104807943A - Determination method of glucose content in glucose injection - Google Patents

Determination method of glucose content in glucose injection Download PDF

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Publication number
CN104807943A
CN104807943A CN201510243151.4A CN201510243151A CN104807943A CN 104807943 A CN104807943 A CN 104807943A CN 201510243151 A CN201510243151 A CN 201510243151A CN 104807943 A CN104807943 A CN 104807943A
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China
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performance liquid
glucose
acetonitrile
high performance
water
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CN201510243151.4A
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CN104807943B (en
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陈学松
郭振旺
黄蘅
文俊萍
张云平
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Guangxi Yu Yuan pharmaceutcal corporation, Ltd
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Wuzhou Institutes for Food and Drug Control
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Abstract

The invention discloses a determination method of the glucose content in a glucose injection. The determination method is characterized by comprising the following steps of: (1) sample pretreatment: taking 50 mg of glucose injection samples, and diluting with 30 ml of water to a constant volume of 100 ml with acetonitrile; (2) analyzing by adopting high-performance liquid chromatography, wherein parameter settings of analysis by adopting the high-performance liquid chromatography are as follows: a mobile phase is acetonitrile-water, the flow rate is 0.8 ml/min, the column temperature is 40 DEG C, and a chromatographic column is a Thermo Acclaim mixed substrate chromatographic column of 4.6 mum*250 mm, 5 mum. The invention aims to provide the determination method of the glucose content in the glucose injection, which has the advantages of accuracy in determination and simplicity in operation.

Description

A kind of assay method of glucose in injection
Technical field
The present invention relates to detection field, particularly a kind of assay method of glucose in injection.
Background technology
Chinese Pharmacopoeia 2010 editions describes the method for glucose assays in glucose injection, and its 3.6.1 saves record and adopts Optical Rotation to measure the content of the glucose in parenteral solution, and the method is high to environment temperature control overflow, larger by such environmental effects during mensuration.
Summary of the invention
The object of the present invention is to provide a kind of assay method measuring glucose in injection accurate, simple to operate.
Technical scheme of the present invention is: a kind of assay method of glucose in injection, comprises the following steps:
Step 1: sample pretreatment, is settled to 100ml with acetonitrile after getting the dilution of glucose injection sample 50mg 30ml water;
Step 2: adopt high performance liquid chromatography to analyze;
The optimum configurations that high performance liquid chromatography carries out analyzing is as follows:
Mobile phase: acetonitrile-water; Flow velocity: 0.8ml/min; Column temperature: 40 DEG C;
Chromatographic column: Thermo Acclaim mixed-matrix chromatographic column, 4.6 μm × 250mm, 5 μm; In described mobile phase, the volume ratio of acetonitrile and water is 60:40 ~ 75:25; The volume ratio of described mobile phase acetonitrile and water in 0 minute to 15-min period rises to 75:25 by 60:40 uniformly; Then in 15 minutes to 30 minutes sections, the volume ratio of acetonitrile and water is constant in 75:25;
The model of described high performance liquid chromatograph is: hermo U3000 high performance liquid chromatograph, the subsidiary Corona Ultra electron spray detecting device of described hermo U3000 high performance liquid chromatograph; Described Corona Ultra electron spray detecting device is used for the solute transfer charge of the Thermo Acclaim mixed-matrix chromatographic column mobile phase out of high performance liquid chromatograph, and by the gatherer of Corona Ultra electron spray detecting device detect solute the electrically charged concentration determining solute.
In the assay method of above-mentioned glucose in injection, described Corona Ultra electron spray detecting device is connected with the outlet of Thermo Acclaim mixed-matrix chromatographic column.
Beneficial effect of the present invention is as follows:
The method that the present invention adopts the eluent ratio of different time to gradually change improves the elution speed of glucose, adopt such scheme effectively can improve the measuring accuracy of glucose in glucose injection, avoid the impact of environment temperature on the measuring accuracy of glucose.
Embodiment
Below in conjunction with embodiment, technical scheme of the present invention is described in further detail, but does not form any limitation of the invention.
Embodiment 1
An assay method for glucose in injection, comprises the following steps:
Step 1: sample pretreatment, is settled to 100ml with acetonitrile after getting the dilution of glucose injection sample 50mg 30ml water;
Step 2: adopt high performance liquid chromatography to analyze;
The optimum configurations that high performance liquid chromatography carries out analyzing is as follows:
Mobile phase: acetonitrile-water; Flow velocity: 0.8ml/min; Column temperature: 40 DEG C;
Chromatographic column: Thermo Acclaim mixed-matrix chromatographic column, 4.6 μm × 250mm, 5 μm; In described mobile phase, the volume ratio of acetonitrile and water is 60:40 ~ 75:25; The volume ratio of described mobile phase acetonitrile and water in 0 minute to 15-min period rises to 75:25 by 60:40 uniformly; Then in 15 minutes to 30 minutes sections, the volume ratio of acetonitrile and water is constant in 75:25;
The model of described high performance liquid chromatograph is: hermo U3000 high performance liquid chromatograph, the subsidiary Corona Ultra electron spray detecting device of described hermo U3000 high performance liquid chromatograph; Described Corona Ultra electron spray detecting device is used for the solute transfer charge to the Thermo Acclaim mixed-matrix chromatographic column mobile phase out of high performance liquid chromatograph, and by the gatherer of Corona Ultra electron spray detecting device detect solute the electrically charged concentration determining solute, described Corona Ultra electron spray detecting device is connected with the outlet of Thermo Acclaim mixed-matrix chromatographic column.
The principle of work of Corona Ultra electron spray detecting device (CAD) technology is that analysis thing is changed into particles of solute.The size of particle increases along with the content of analyte; Particles of solute and positively charged nitrogen particle bump against, and electric charge transfers to (particles of solute is larger, charged more) on particle thereupon; Particles of solute to gatherer, measures the carried charge of particles of solute their Charger transfer by highly sensitive electrostatic detection, consequent marking current is directly proportional to the content of solute.Testing result is relevant with analyte particles, and marking current is directly proportional to the quality analyzing thing in sample.
Above-mentioned method of testing adopts the mode of gradient elution to carry out wash-out, effective separation of composition to be measured can be realized in wider scope, simultaneously, employing Corona Ultra electron spray detecting device can realize Measurement accuracy during extremely low concentration, the instability that the manual operation overcoming conventional test methodologies brings.
Above-describedly be only preferred embodiment of the present invention, all do within the scope of the spirit and principles in the present invention any amendment, equivalently to replace and improvement etc., all should be included within protection scope of the present invention.

Claims (2)

1. an assay method for glucose in injection, is characterized in that, comprises the following steps:
Step 1: sample pretreatment, is settled to 100ml with acetonitrile after getting the dilution of glucose injection sample 50mg 30ml water;
Step 2: adopt high performance liquid chromatography to analyze;
The optimum configurations that high performance liquid chromatography carries out analyzing is as follows:
Mobile phase: acetonitrile-water; Flow velocity: 0.8ml/min; Column temperature: 40 DEG C;
Chromatographic column: Thermo Acclaim mixed-matrix chromatographic column, 4.6 μm × 250mm, 5 μm; In described mobile phase, the volume ratio of acetonitrile and water is 60:40 ~ 75:25; The volume ratio of described mobile phase acetonitrile and water in 0 minute to 15-min period rises to 75:25 by 60:40 uniformly; Then in 15 minutes to 30 minutes sections, the volume ratio of acetonitrile and water is constant in 75:25;
The model of described high performance liquid chromatograph is: hermo U3000 high performance liquid chromatograph, the subsidiary Corona Ultra electron spray detecting device of described hermo U3000 high performance liquid chromatograph; Described Corona Ultra electron spray detecting device is used for the solute transfer charge of the Thermo Acclaim mixed-matrix chromatographic column mobile phase out of high performance liquid chromatograph, and by the gatherer of Corona Ultra electron spray detecting device detect solute the electrically charged concentration determining solute.
2. the assay method of glucose in injection according to claim 1, is characterized in that, described Corona Ultra electron spray detecting device is connected with the outlet of Thermo Acclaim mixed-matrix chromatographic column.
CN201510243151.4A 2015-05-12 2015-05-12 A kind of assay method of glucose in injection Active CN104807943B (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114088833A (en) * 2021-11-17 2022-02-25 广州浩宇生物科技有限公司 Method for rapidly detecting glucose content in food

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CN103267821A (en) * 2013-05-17 2013-08-28 四川农业大学 HPLC-ELSD (high performance liquid chromatography-evaporation light-scattering detection) measuring method of grape berry sugar
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JP2008170428A (en) * 2006-12-12 2008-07-24 Keio Gijuku Hplc analysis for sugar and sugar-alcohol
CN103267821A (en) * 2013-05-17 2013-08-28 四川农业大学 HPLC-ELSD (high performance liquid chromatography-evaporation light-scattering detection) measuring method of grape berry sugar
CN103543222A (en) * 2013-10-01 2014-01-29 江苏康缘药业股份有限公司 Reduning injection saccharide content detection method

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114088833A (en) * 2021-11-17 2022-02-25 广州浩宇生物科技有限公司 Method for rapidly detecting glucose content in food

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Effective date of registration: 20170407

Address after: 543000 Pubei Wuzhou County Industrial Zone, Guangxi

Patentee after: Guangxi Yu Yuan pharmaceutcal corporation, Ltd

Address before: 543000 the Guangxi Zhuang Autonomous Region, Wuzhou West Ring Road, No. 198

Patentee before: WUZHOU INSTITUTES FOR FOOD AND DRUG CONTROL

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Address after: 535000, the Guangxi Zhuang Autonomous Region County, Pubei City, Qinzhou Industrial Zone

Patentee after: Guangxi Yu Yuan pharmaceutcal corporation, Ltd

Address before: 543000 Pubei Wuzhou County Industrial Zone, Guangxi

Patentee before: Guangxi Yu Yuan pharmaceutcal corporation, Ltd