High performance liquid chromatography analysis method for measuring sodium sulfite content

A high-performance liquid chromatography and sodium sulfite technology, applied in the field of drug detection, can solve problems such as inseparability, poor solution stability, and low sensitivity, and achieve high recovery, high sensitivity, and short analysis time.

Active Publication Date: 2013-06-26
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

(2) Quantify sodium sulfite by using the reaction between sodium sulfite and acid to generate sulfur dioxide that can fade the acidic magenta, but the sensitivity of this method is not high
(3) Utilize its complexation with the complexing agent to develop color, and measure it by ultraviolet-visible spectrophotometry; if sodium sulfite is determined by this method, other components must not complex with the complexing agent to develop color, and the color of the complex Poor solution stability
But sulphite ion does not have retention substantially on C18, C8 chromatographic column, can't separate with other ions such as thiosulfate ion, the method for measuring sodium sulphite content with high performance liquid chromatography has not yet seen the open report at present, therefore needs Establish a method that can quickly and accurately determine the content of sodium sulfite

Method used

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  • High performance liquid chromatography analysis method for measuring sodium sulfite content
  • High performance liquid chromatography analysis method for measuring sodium sulfite content
  • High performance liquid chromatography analysis method for measuring sodium sulfite content

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The selection of embodiment 1 chromatographic conditions

[0031] 1.1 Selection of wavelength

[0032] Take the standard solution, use the mobile phase as the blank calibration solution, and scan at 190nm to 400nm according to the ultraviolet-visible spectrophotometric method (Appendix IV A of Part Two of the Chinese Pharmacopoeia 2010 Edition). The result shows that need testing solution has maximum absorption peak at 214nm place. Therefore, 214nm±5nm was determined as the detection wavelength.

[0033] 1.2 Method screening test

[0034] In this test, the chromatographic method of this test is screened by adjusting the composition and ratio of the mobile phase, pH value, flow rate, column temperature, etc. See Table 1 for specific plans.

[0035] Table 1 Screening scheme of the method

[0036]

[0037] Precisely measure 1ml of sodium thiosulfate injection, put it in a 25ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it as the...

Embodiment 2

[0042] The stability of embodiment 2 solution

[0043] Take by weighing about 14 mg of anhydrous sodium sulfite, accurately weigh it, put it in a 25ml measuring bottle, dissolve it with the mobile phase in Scheme 3 in Example 1 and dilute to the mark, shake it up, and use it as reference solution 1; in addition, take anhydrous sodium sulfite About 14mg, accurately weighed, put in 25ml measuring bottle, dissolve and dilute to scale with the mobile phase in scheme 6 in embodiment 1, shake up, as reference substance solution two.

[0044] Precisely measure 5 μl of the reference substance solution at 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours, test according to the chromatographic conditions of scheme 3, and record the chromatograms. In addition, at 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours, 5 μl of the reference substance solution was accurately measured, and the test was carried out according to the chromatographic conditions of scheme 6, and the chromatograms were re...

Embodiment 3

[0049] Embodiment 3 The making of standard curve

[0050] Chromatographic conditions: the same as the chromatographic conditions described in Scheme 3 in Example 1.

[0051]Weigh 28.1mg, 21.7mg, 14.3mg, and 7.6mg of anhydrous sodium sulfite, put them in 25ml measuring bottles, add an appropriate amount of mobile phase, shake to dissolve, add mobile phase to the scale, shake well, and use it as a linear solution 1 to 4 . Precisely measure 1ml each of linear solution 1 and linear solution 3, respectively, put them in 10ml measuring bottles, add mobile phase to the mark, shake well, and use them as linear solutions 5 and 6. For the chromatogram of linear solution 3 see figure 2 .

[0052] Take the linear solution of sodium sulfite for injection, and plot the peak area and concentration (see image 3 ). Sodium sulfite solution is linear in the range of 56.0 μg / ml to 1100.4 μg / ml, and the linear regression equation is:

[0053] A=3.5518C+22.0731, correlation coefficient r=...

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Abstract

The invention discloses a method for measuring sodium sulfite content through high performance liquid chromatography. The method uses octadecylsilane chemically bonded silica as a filling agent, and uses tetrabutylammonium hydrogen sulfate-added phosphate buffer solution-methanol as mobile phases, wherein the volume ratio of the buffer solution to the methanol is 90: 10 to 70: 30; the detection wavelength is 214+/-5nm; and the flow rate is 0.5 to 1.2ml/min. By adopting the method, the sulfite ion can be effectively separated from other similar ions, and the sulfite ion can be accurately quantified. The method is high in specificity, excellent in precision, high in accuracy, and capable of quickly and accurately measuring the sodium sulfite content.

Description

technical field [0001] The invention relates to a drug detection method, in particular to a high-performance liquid chromatography analysis method for determining the content of sodium sulfite. Background technique [0002] Sodium sulfite has reducing properties and can be widely used in injections as an antioxidant. Because sodium sulfite has certain toxic and side effects on the human body, in recent years, the control of the dosage of such antioxidants in injections has become more and more stringent, not only the limit requirement, but the accurate determination of its content. At present, there are three types of methods for determining the content of sodium sulfite: (1) usually use its reducing property to titrate with iodine titration solution and sodium thiosulfate; if this method is used to determine sodium sulfite, other components in the sample must not have reducing properties. (2) The sulfur dioxide produced by the reaction of sodium sulfite with acid can make...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/60
Inventor 陈剑锋李睿
Owner YAOPHARMA CO LTD
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