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A kind of assay method of sodium chloride content in sodium chloride injection

A technology for sodium chloride injection and a determination method, which is applied in the field of determination of sodium chloride content in sodium chloride injection, can solve problems such as high professional skill requirements and deviation of test results, and achieve the purpose of overcoming instability and avoiding miscellaneous Effect of peak interference, accurate measurement

Active Publication Date: 2016-06-29
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 kind of assay method of sodium chloride content in sodium chloride injection, comprises the following steps:

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

[0019] Step 2: use high performance liquid chromatography for analysis;

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

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

[0022] Chromatographic column: ThermoAcclaim mixed matrix column, 4.6 μm×250 mm, 5 μm; the volume ratio of ethanol and water in the mobile phase is 60:40 to 70:30; the mobile phase is in the period of 0 to 7 minutes The volume ratio of ethanol and water 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: ThermoU3000 high performanc...

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Abstract

The invention discloses a method for determining the content of sodium chloride in sodium chloride injection, which comprises the following steps: step 1: sample pretreatment, taking 50 mg of the sample and dissolving it in 35 ml of water, and distilling it to 100 ml with ethanol; step 2: using High-performance liquid chromatography was used for analysis; the parameters for high-performance liquid chromatography for analysis were set as follows: mobile phase: ethanol-water; flow rate: 1ml / min; column temperature: 45°C. The object of the present invention is to provide the assay method of sodium chloride content in the sodium chloride injection that measures accurately, simple to operate.

Description

technical field [0001] The invention relates to the field of detection, in particular to a method for determining the content of sodium chloride in a 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 injection. This method requires high professional skills for operators. , there is a certain deviation in the test results of different testers. SUMMARY OF THE INVENTION [0003] The object of the present invention is to provide a kind of determination method of sodium chloride content in the sodium chloride injection that is accurate and simple to operate. [0004] The technical scheme of the present invention is: a method for measuring the content of sodium chloride in a sodium chloride injection, comprising the following steps: ...

Claims

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Application Information

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Patent Type & Authority Patents(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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