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Determining method for EDTA-2Na content in terbutaline sulfate atomized solution

A technology of terbutaline sulfate and atomized liquid, which is applied in the field of high performance liquid chromatography, can solve the problems of unreported detection methods of inhalation preparations, and achieve improved quality controllability, strong specificity, stable and uniform quality Effect

Inactive Publication Date: 2019-08-13
南京华盖制药有限公司
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Problems solved by technology

[0003] The 2015 edition of "Chinese Pharmacopoeia" contains the quality standards of edetate disodium and edetate calcium sodium injection. At present, the content determination of edetate disodium is concentrated in the injection and eye drop formulations. The detection method has not been reported

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  • Determining method for EDTA-2Na content in terbutaline sulfate atomized solution
  • Determining method for EDTA-2Na content in terbutaline sulfate atomized solution
  • Determining method for EDTA-2Na content in terbutaline sulfate atomized solution

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Embodiment 1

[0028] (1) Preparation of standard reference substance solution: Weigh an appropriate amount of EDTA-2Na reference substance, accurately weigh it, dissolve and dilute it with water to make a 0.1mg / ml solution, accurately measure 1ml, put it in a 10ml measuring bottle, and add the mass fraction Dilute the 0.02% copper sulfate solution to the mark, shake well to prepare the stock solution;

[0029] (2) Preparation of sample solution: Accurately measure 2ml of sample, put it in a 20ml measuring bottle, add 10ml of copper sulfate solution with a mass fraction of 0.02%, dilute to the mark with pure water, and shake well.

[0030] (3) After the baseline of the instrument is stable, measure the standard reference solution and the sample solution respectively with a high-performance liquid chromatograph, and the instrument is Dianne U3000;

[0031] Mobile phase: acetonitrile: 0.006M tetrabutylammonium hydroxide aqueous solution = 1:4, isocratic elution;

[0032] Column temperature: 3...

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Abstract

The method of a high-precision method for EDTA-2Na content in an terbutaline sulfate atomized solution. The method comprises: (1) using sample reference; (2) using sample performance; (3) using high performance liquid chromatography to determine the Different Concentration of the standard reference solutions and the sample solutions, to be more specific, a mobile phase comprises acetonitrile and a0.006 M tetrabutyl ammonium hydroxide aqueous solution in the ratio of 1:4, then isocratic elution is carried out, a column temperature is 30 Degree Celsius, a flow rate is 1.0 mL / min, a detectionwavelength is 254 nm, injection amount is 25 MuL, and a chromatographic column is a C18 column with the inner diameter of 4.6 mm, column height of 150 mm and packing pore diameter of And um recordingthe concentrations and corresponding peak areas of the standard reference o Lutions and peak area of the sample solutions; (4) using the external standard method to determine The corresponding EDTA-2Na content according to the peak area of the sample solutions.

Description

technical field [0001] The invention relates to the technical field of high performance liquid chromatography, in particular to a method for measuring the content of EDTA-2Na in terbutaline sulfate atomized liquid by using high performance liquid chromatography. Background technique [0002] Edetic acid and edetate salts are used as metal chelating agents in pharmaceutical preparations, which can form stable water-soluble complexes with alkaline earth metal and heavy metal ions, and play an antioxidant and stabilizing role in pharmaceutical dosage forms. Among them, edetate disodium is also called edetate disodium, EDTA-2Na. [0003] The 2015 edition of "Chinese Pharmacopoeia" contains the quality standards of edetate disodium and edetate calcium sodium injection. At present, the content determination of edetate disodium is concentrated in the injection and eye drop formulations. The detection method has not been reported. [0004] Therefore, it is necessary to improve the...

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 孙向阳朱景阳仝朝辉张聪霞龚勋张明月
Owner 南京华盖制药有限公司
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