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HPLC-CAD method used for measuring content of sodium in glucose and sodium chloride injection

A technology of HPLC-CAD, glucose and sodium chloride, applied in the field of chemical detection, can solve the problems of unrecorded sodium content, non-compliance, etc., and achieve the effects of overcoming instability, easy operation and excellent performance

Inactive Publication Date: 2018-07-31
WUZHOU INST FOR FOOD & DRUG CONTROL
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Problems solved by technology

The HPLC-CAD method for measuring the sodium content in glucose sodium chloride injection is not recorded in the existing national standards. Even if the traditional HPLC measurement method is used, the linearity rate does not obey the strict linear distribution standard in the entire measurement range.

Method used

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  • HPLC-CAD method used for measuring content of sodium in glucose and sodium chloride injection

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Embodiment 1

[0029] 1 Instruments and reagents

[0030] Thermo-U3000 high-performance liquid chromatography (Thermo Electric Company of the United States, with Corona Ultra electrospray detector), the chromatographic column is Thermo Mixed-Mode Hilic (2.1×150mm, 1.3μm).

[0031] Ammonium acetate (analytical pure, Shanghai Aladdin Biochemical Technology Co., Ltd.);

[0032] Sodium chloride reference substance (batch number: GBW(E)060024, China Institute of Metrology, content=99.99%);

[0033] 250ml glucose sodium chloride injection (lot number: E131102K2, Hunan Kelun Pharmaceutical Co., Ltd.); 250ml glucose sodium chloride injection (lot number: 131228804, Anhui Shuanghe Pharmaceutical Co., Ltd.); 250ml glucose sodium chloride injection ( Batch number: H13121609, Guangxi Yuyuan Pharmaceutical Co., Ltd.); all provided by the hospital;

[0034] Acetonitrile (chromatographically pure, U.S. Sigma-aldrich company);

[0035] The methanol used for extraction is ultra-pure methanol.

[0036] 2....

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Abstract

The invention discloses a HPLC-CAD method used for measuring content of sodium in glucose and sodium chloride injection, and belongs to the field of chemical detection. The HPLC-CAD method used for measuring content of sodium in glucose and sodium chloride injection is accurate in measuring, and simple in operation, and comprises following steps successively: 1, preparation of a tested object solution, wherein 1ml of glucose and sodium chloride injection is diluted with methanol to 1000ml, an obtained mixture is shaken to be uniform, and is filtered; 2, preparation of a reference solution, wherein 15g of a sodium chloride reference substrate is weighted accurately, and is introduced into a 250ml measuring flask, methanol is added for dissolving and dilution to a constant volume, and an obtained mixed solution is shaken to be uniform; and 3, high performance liquid chromatography analysis. The HPLC-CAD method can be used for replacing a conventional detection method in measuring of thecontent of sodium in glucose and sodium chloride injection.

Description

technical field [0001] The invention relates to the field of chemical detection, in particular to a method for measuring sodium content in glucose sodium chloride injection by HPLC-CAD. Background technique [0002] Section 3.6.2 of the Chinese Pharmacopoeia 2010 Edition records that silver nitrate titration is used to determine the content of sodium chloride in the injection. This method requires high professional skills of operators, and there are certain deviations in the test results of different testers. The HPLC-CAD method for measuring the sodium content in glucose sodium chloride injection is not recorded in the existing national standard. Even if the traditional HPLC measurement method is used, the linearity rate does not obey the strict linear distribution standard in the entire measurement range. . [0003] Electrospray detector (CAD) is a common detector at present. When used in conjunction with HPLC, the HPLC eluent is atomized by the action of nitrogen in the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 陈学松钟水桥梁峰
Owner WUZHOU INST FOR FOOD & DRUG CONTROL
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