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Method for determining content of glucose and sodium chloride in sodium chloride and dextrose injection

A technology of glucose and sodium chloride and a determination method, which is applied in the field of determination of glucose and sodium chloride content in glucose and sodium chloride injection, can solve the problems of non-compliance, high requirements for operators' professional skills, and high requirements for environmental temperature control

Active Publication Date: 2015-09-23
WUZHOU INST FOR FOOD & DRUG CONTROL
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Problems solved by technology

[0002] The 2010 edition of the Chinese Pharmacopoeia records the method for the determination of glucose in glucose injection. Section 3.6.1 records that the content of glucose in the injection is determined by the optical polarimetry method. This method has high requirements for environmental temperature control and is less affected by environmental factors during determination Large, its section 3.6.2 records the use of silver nitrate titration to determine the content of sodium chloride in the injection. This method requires high professional skills of the operators, and there are certain deviations in the test results of different testers.
The existing national standard does not record the simultaneous measurement of glucose and sodium chloride content in glucose and sodium chloride injection. Even if the traditional HPLC measurement method is used, the linearity rate does not obey a strict linear distribution in the entire measurement range. standard

Method used

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Embodiment 1

[0023] A kind of assay method of glucose and sodium chloride content in glucose sodium chloride injection, comprises the following steps:

[0024] Step 1: Sample pretreatment, take 50mg of glucose sodium chloride injection and dilute with 40ml of water, then dilute to 100ml with acetonitrile;

[0025] Step 2: analyze by high performance liquid chromatography;

[0026] The parameters for HPLC analysis were set as follows:

[0027] Mobile phase: acetonitrile-water; flow rate: 1ml / min; column temperature: 40°C;

[0028] Chromatographic column: Thermo Acclaim mixed matrix chromatographic column, 4.6μm×250mm, 5μm;

[0029] The volume ratio of acetonitrile and water in the mobile phase is 50:50 to 80:20; the mobile phase is added by gradient elution, and the specific parameters are as follows:

[0030] The total elution time is 25 minutes;

[0031] At minute 0, the volume ratio of acetonitrile and water in the mobile phase was 50:50;

[0032] In the 6th minute, the volume ratio...

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Abstract

The invention discloses a method for determining content of glucose and sodium chloride in sodium chloride and dextrose injection. The method comprises the following steps: step1, performing sample pretreatment, and diluting 50mg of sodium chloride and dextrose injection with 40ml of water, and adding acetonitrile to constant volume of 100ml; step2, analyzing by high performance liquid chromatography; parameters of the high performance liquid chromatography are set as follows: mobile phase: acetonitrile-water; flow rate: 1ml / min; column temperature: 40 DEG C; chromatographic column: Thermo Acclaim mixed-matrix chromatographic column, 4.6mum*250mm, 5mum. The invention aims at providing the method for determining the content of the glucose and the sodium chloride in the sodium chloride and dextrose injection, which is accurate in determination and simple in operation.

Description

technical field [0001] The invention relates to the detection field, in particular to a method for determining the content of glucose and sodium chloride in glucose and sodium chloride injection. Background technique [0002] The 2010 edition of the Chinese Pharmacopoeia records the method for the determination of glucose in glucose injection. Section 3.6.1 records that the content of glucose in the injection is determined by the optical polarimetry method. This method has high requirements for environmental temperature control and is less affected by environmental factors during determination Big, its section 3.6.2 records that the content of sodium chloride in the injection is determined by silver nitrate titration method. This method requires high professional skills of operators, and there are certain deviations in the test results of different testers. The existing national standard does not record the simultaneous measurement of glucose and sodium chloride content in g...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 陈学松陈启钊黄蘅蔡姬灵张云平
Owner WUZHOU INST FOR FOOD & DRUG CONTROL
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