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High performance liquid chromatographic analysis method for testing content of edetate disodium

A technology of high performance liquid chromatography and disodium edetate is applied in the field of high performance liquid chromatography analysis for determining the content of disodium edetate, and can solve the problem that the complex of disodium edetate cannot be effectively distinguished and the preparation of titrant is cumbersome. , the measurement results are biased and other problems, to achieve the effect of fast and accurate determination, high recovery rate and high sensitivity

Inactive Publication Date: 2018-10-09
江苏华泰疫苗工程技术研究有限公司 +2
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Problems solved by technology

The method used for the determination of edetate disodium raw material content is still the titration method ([M] Chinese Pharmacopoeia 2015 edition, fourth part, 523-524, [M] European Pharmacopoeia 7.5, 1824-1825), because this method cannot be effective Distinguishing disodium edetate complexes from other complexes, the preparation of the titration solution is tedious and time-consuming, the end point of the indicator is judged by human eyes, which is prone to subjectivity, and the measurement results are often biased

Method used

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  • High performance liquid chromatographic analysis method for testing content of edetate disodium
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  • High performance liquid chromatographic analysis method for testing content of edetate disodium

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Embodiment 1 Sampling precision

[0040] Table 1 Peak areas of 6 repeated injections of the same standard solution

[0041] Number of injections

[0042] The average peak area of ​​the six injections of the same standard solution was 196.2, and the RSD was 0.23%. The results showed that the method had high precision in detecting the content of edetate disodium.

Embodiment 2

[0043] Embodiment 2 linear relationship test

[0044] Essence is taken reference substance stock solution appropriate amount, is respectively 3, 6, 15, 30, 60, 75ug, 100ug / ml linearity test standard solution with diluent dilution and makes serial concentration, by the method of the present invention sample introduction detection, to standard substance Solution concentration (X) and peak area (Y) carry out data regression analysis, linear relationship such as Figure 4 As shown, the regression equation is Y=6.5558x+0.8932, r=1.0000. The results showed that the peak area of ​​disodium edetate had a good linear relationship with the solution concentration in the range of 3-100 μg / ml solution concentration.

Embodiment 3

[0045] Embodiment 3 detection limit and quantitative limit

[0046] Take the control solution with a concentration of 30 μg / ml under the item of linearity and range and serially dilute it, then inject the sample for detection, and calculate according to the signal-to-noise ratio of about 3,

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Abstract

The invention discloses a high performance liquid chromatographic analysis method for testing the content of edetate disodium. According to the method, octadecyl silane bonded silica gel is adopted asa filling agent, ferric sulfate is adopted as a diluent, a sodium acetate buffer solution-acetonitrile with tetrabutylammonium chloride is adopted as a mobile phase, the ratio of the buffer solutionto acetonitrile is 4 to 6, a detection wavelength is 350nm, a flowing velocity is 1.0ml / minute, and a feeding volume is 25mu l. By adopting the method, edetic acid radical ions can be effectively separated and accurately quantified. The method is good in specificity, good in precision and high in accuracy, and is capable of rapidly and accurately testing the content of edetate disodium.

Description

technical field [0001] The present invention relates to the detection method of food, medicine, health product and cosmetic etc., specifically relates to a kind of high performance liquid chromatographic analysis method of measuring the content of disodium edetate. Background technique [0002] Edetate disodium is a strong complexing agent, widely used in food, medicine, chemical industry and other fields (Claudia Oviedo.EDTA: The chelating agent under environmental scrutiny [J] Quim.Nova, Vol.26, No.6, 901 -905, 2003). Mainly used as antioxidant synergist, antibacterial synergist, water softener and anticoagulant (Raymond C Rowe, Paul J Sheskey and Sian C Owen. Handbook of Pharmaceutical Excipients. Fourth Edition. [M] London, Chicago: Pharmaceutical Press, 2003). According to literature reports, edetate disodium is easy to combine with calcium. In the case of long-term high-dose use or too fast intravenous infusion, edetate disodium can combine with calcium in blood and ...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74G01N30/86
CPCG01N30/06G01N30/74G01N30/8634
Inventor 赵述强李健峰居斌武琳琳袁耀佐张玫史清水樊夏雷
Owner 江苏华泰疫苗工程技术研究有限公司
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