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Method for detecting sodium chloride content in sodium chloride injection

A technology for sodium chloride injection and determination method, applied in the field of determination of sodium chloride content in sodium chloride injection, can solve problems such as high professional skill requirements, deviation of test results, etc., to overcome instability and avoid errors , the effect of avoiding the interference of spurious peaks

Active Publication Date: 2015-07-22
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 sodium chloride in sodium chloride injection. 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 for operators , there is a certain deviation in the test results of different testers

Method used

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Experimental program
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Embodiment 1

[0017] A method for assaying sodium chloride content in sodium chloride injection, comprising the following steps:

[0018] Step 1: Sample pretreatment, take 50mg of sample and dissolve it with 35ml of water, then dilute to 100ml with ethanol;

[0019] Step 2: analyze by high performance liquid chromatography;

[0020] The parameters for HPLC analysis were set as follows:

[0021] Mobile phase: ethanol-water; flow rate: 1ml / min; column temperature: 45°C;

[0022] Chromatographic column: Thermo Acclaim mixed matrix chromatographic column, 4.6μm×250mm, 5μm; the volume ratio of ethanol and water in the mobile phase is 60:40~70:30; The volume ratio of ethanol and water in the period is uniformly increased from 60:40 to 70:30; then the volume ratio of ethanol and water is constant at 70:30 in the period of 7 minutes to 25 minutes;

[0023] The model of the described high-performance liquid chromatograph is: hermo U3000 high-performance liquid chromatograph, and described hermo U...

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Abstract

The invention discloses a method for detecting sodium chloride content in sodium chloride injection. The method comprises the following steps: 1, sample pretreatment, namely dissolving 50mg of a sample by 35ml of water, fixing the volume to be constant to 100ml by ethyl alcohol; and 2, analyzing by high performance liquid chromatography, wherein the parameters of the high performance liquid chromatography are set as follows: the flowing phase is ethyl alcohol-water, the flow rate is 1ml / min, and the column temperature is 45 degree centigrade. The invention aims to provides the method for detecting sodium chloride content in sodium chloride injection which is accuracy in detection and easy to operate.

Description

technical field [0001] The invention relates to the detection field, in particular to a method for determining the content of sodium chloride in sodium chloride injection. Background technique [0002] The 2010 edition of the Chinese Pharmacopoeia records the method for the determination of sodium chloride in sodium chloride injection. 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 for operators , There is a certain deviation in the test results of different testers. Contents of the invention [0003] The object of the present invention is to provide a kind of assay method of sodium chloride content in the sodium chloride injection that measures accurately, simple to operate. [0004] The technical scheme of the present invention is: a kind of assay method of sodium chloride content in sodium chloride injection, comprises the following steps: [0005] St...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 陈学松赖秀梅黄蘅黎志锐张云平
Owner WUZHOU INST FOR FOOD & DRUG CONTROL
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