Method for simultaneous determination of dichloroacetic acid, gluconic acid and acetic acid in compound diisopropylamine dichloroacetate tablets by ion chromatography

A technology of compound diisopropylamine dichloroacetate tablets and diisopropylamine dichloroacetate, which is applied in the field of analytical chemistry to achieve the effects of strong practicability, no interference in operation, and high accuracy

Active Publication Date: 2012-07-11
ANHUI WAYEE SCI & TECH CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The method for the simultaneous detection of diisopropylamine dichloroacetate, sodium gluconate and by-product acetic acid has not yet been reported

Method used

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  • Method for simultaneous determination of dichloroacetic acid, gluconic acid and acetic acid in compound diisopropylamine dichloroacetate tablets by ion chromatography
  • Method for simultaneous determination of dichloroacetic acid, gluconic acid and acetic acid in compound diisopropylamine dichloroacetate tablets by ion chromatography
  • Method for simultaneous determination of dichloroacetic acid, gluconic acid and acetic acid in compound diisopropylamine dichloroacetate tablets by ion chromatography

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Experimental program
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Effect test

Embodiment 1

[0038] Embodiment 1: the selection of eluent concentration

[0039] The sodium carbonate eluents of different concentrations (2, 3.6, 4mmol / L) were investigated, and the test showed that in the sodium carbonate eluents of 2mmol / L, gluconic acid and small molecular organic acids achieved baseline separation, but dichloroacetic acid The peak eluting time is too long; and choose 4mmol / L sodium carbonate eluent, although the peak eluting time of dichloroacetic acid is shortened, gluconic acid and small molecular organic acids cannot achieve baseline separation; therefore, the final choice is 3.5mmol / L The sodium carbonate eluent not only ensures the baseline separation of gluconic acid and small molecular organic acids, but also ensures that the retention time of dichloroacetic acid is shortened. The experimental results are better, see figure 1 .

Embodiment 2

[0040] Embodiment 2: Precision experiment, linear relationship and detection limit

[0041] Get an appropriate amount of stock solution to be formulated into mass concentrations of 0.25, 0.5, 2.5, 5.0, 10mg / L of gluconic acid, acetic acid and dichloroacetic acid mixed reference substance standard solution, under the described chromatographic conditions, draw gluconic acid, acetic acid and The working curve of dichloroacetic acid (see figure 2 , 3, 4). The results showed that the concentration of gluconic acid, acetic acid and dichloroacetic acid (C 葡萄糖酸 , C 乙酸 , C DCA , mg / L) within a certain range and peak height (H, MV) in a good linear relationship. (Consistent) According to 3 times the signal-to-noise ratio (S / N), determine the detection limit of the method, which is listed in Attached Table 1. The standard solutions of 2.5 mg / L gluconic acid, acetic acid and dichloroacetic acid were measured in parallel six times, and the relative standard deviations (RSD%) were 0.7...

Embodiment 3

[0045] Embodiment 3: compound diisopropylamine dichloroacetate sheet sample analysis

[0046] Under the selected chromatographic conditions, inject the processed compound diisopropylamine dichloroacetate tablet sample into the ion chromatographic instrument for analysis, record the chromatographic peak of the component to be measured in the sample through the chromatographic workstation, and obtain the peak height of the component to be measured at the same time value. Put the peak height value into the linear equation of the components to be tested, and then the concentration of each component to be tested (see Table 2) is obtained from the attached Figure 5 It can be seen that the main components of gluconic acid, dichloroacetic acid and acetic acid in the sample are not disturbed, which ensures the accuracy of the actual sample detection.

[0047] Schedule 2

[0048]

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Abstract

The invention discloses a method for simultaneous determination of dichloroacetic acid, gluconic acid and acetic acid in compound diisopropylamine dichloroacetate tablets by ion chromatography. The contents of dichloroacetic acid, gluconic acid and acetic acid in compound diisopropylamine dichloroacetate tablets aqueous solution are measured by ion chromatography, and then are converted to the contents of diisopropylamine dichloroacetate, sodium gluconate and sodium acetate by formulas. The method disclosed by the invention is used for monitoring a production process of compound diisopropylamine dichloroacetate tablets, has the characteristics of rapidness, simplicity, no interference, high accuracy and simplicity and feasibility in operation, and has strong practicability in improvement of pharmaceutical synthesis process and product quality control.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and relates to a method for quantitatively determining the contents of dichloroacetic acid, gluconic acid and acetic acid, the main components in compound diisopropylamine dichloroacetate tablets, and in particular to an ion chromatography method for determining the content of compound diisopropylamine dichloroacetate tablets The main components dichloroacetic acid and gluconic acid and impurity acetic acid content method. Background technique [0002] Diisopropylamine dichloroacetate DADA, also known as Ganle, is an active ingredient of vitamin B15, which can improve liver function and regulate blood lipid metabolism. It is clinically used to prevent and treat fatty liver, acute and chronic hepatitis, early cirrhosis and other liver dysfunction. Sodium gluconate is also one of the main ingredients in this medicine. The method of detecting diisopropylamine dichloroacetate reported in the lit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 焦霞
Owner ANHUI WAYEE SCI & TECH CO LTD
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