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A method for the detection of related substances of metadoxine by high performance liquid chromatography

A high-performance liquid chromatography and metadoxine technology, applied in the field of pharmaceutical analysis, can solve the problems of long sample retention time, small resolution, and ineffective separation of the main component pyroglutamic acid, and achieve accurate and reliable detection results, separation High degree, to avoid the effect of clogging

Active Publication Date: 2019-07-16
SICHUAN TONGSHENG BIOTECH
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] At present, in the prior art, Luna C18(2) and Agilen Zorbax SB-C18 chromatographic columns are used to detect the main components and related substances of metadoxine. When using this chromatographic column for detection, the sample retention time is too long, and the separation However, if you try to shorten the retention time, the related substances and the main component pyroglutamic acid cannot be effectively separated; therefore, it is very important to find a detection method with high resolution, moderate retention time of the main component, that is, short analysis time and low cost. Necessary

Method used

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  • A method for the detection of related substances of metadoxine by high performance liquid chromatography
  • A method for the detection of related substances of metadoxine by high performance liquid chromatography
  • A method for the detection of related substances of metadoxine by high performance liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Metadoxin HPLC detection method:

[0041] (1) Preparation of the test solution: Accurately weigh 5 mg of metadoxine, put it in a 25ml measuring bottle, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the test solution.

[0042] Preparation of reference substance solution: take 5 mg of metadoxine-related substance A, put it in a 25ml measuring bottle, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the reference substance stock solution; accurately measure appropriate amount, quantitatively dilute to make each 0.2μg solution in 1ml, as the reference solution

[0043] Preparation of system suitability test solution: take 5 mg of metadoxine, put it in a 25ml measuring bottle, add mobile phase to dissolve and dilute to the mark, and shake up to obtain a metadoxine solution; take 0.25 ml of the reference substance stock solution, put it in In a 25ml measuring bottle, dilute to the mark with the above-mentioned me...

Embodiment 2

[0063] In the detection conditions, the mobile phase was changed to acetonitrile-water (5%:95%), and the pH value was adjusted to 2.0 with phosphoric acid. Other steps and implementation conditions were the same as in Example 1.

[0064] According to the above detection conditions, take 5 μl of the system suitability test solution and inject it into the liquid chromatograph, record the chromatogram, take 5 μl of the reference substance and inject it into the liquid chromatograph, adjust the detection sensitivity so that the peak height of the main component chromatographic peak is about 10% of the full scale Accurately measure each 5 μ l of the test solution and the reference solution, inject the liquid chromatograph respectively, record the chromatogram, and calculate the content of the test variety metadoxine impurity by the external standard method with the peak area to be about 0.02%.

[0065] Table 2, separation effect of metadoxine main components vitamin B6, pyroglutamic...

Embodiment 3

[0070] In the detection condition, the flow rate becomes 1.0ml / min, and other steps and implementation conditions are the same as in Example 1.

[0071] According to the above detection conditions, take 5 μl of the system suitability test solution and inject it into the liquid chromatograph, record the chromatogram, take 5 μl of the reference substance and inject it into the liquid chromatograph, adjust the detection sensitivity so that the peak height of the main component chromatographic peak is about 10% of the full scale Accurately measure each 5 μ l of the test solution and the reference solution, inject the liquid chromatograph respectively, record the chromatogram, and calculate the content of the test variety metadoxine impurity by the external standard method with the peak area to be about 0.02%.

[0072] Table 3, separation effect of metadoxine main components vitamin B6, pyroglutamic acid, and related substance A under the conditions of Example 3

[0073]

[0074...

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Abstract

Belonging to the technical field of pharmaceutical analysis, the invention in particular relates to a method for detection of metadoxine related substances by high performance liquid chromatography. A metadoxine test solution and a reference solution are detected by high performance liquid chromatography respectively, chromatograms of the two are recorded, a peak area of vitamin B6 in the metadoxine test solution and a main peak area of the reference solution are acquired, and quantitative analysis is carried out on metadoxine related substances by external standard method. The reference solution is a pure metadoxine solution. The method provided by the invention has the advantages of high separation degree, moderate principal component retention time, i.e. short analysis time, and low cost.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a method for detecting metadoxine related substances by high performance liquid chromatography. Background technique [0002] Metadoxine, whose chemical name is pyridoxine L-2 pyrrolidone-5-carboxylate, has a chemical structure as shown below; [0003] [0004] Metadoxine was developed by the Italian Laboratori Baldacci SPA company and was launched in Italy in September 1985 under the trade name Metadoxil; Metadoxine can reduce blood ethanol, and ethanol in the body is mainly converted into ethyl alcohol through alcohol dehydrogenase (ADH). Aldehyde, a small amount is converted to acetaldehyde by microsomal alcohol oxidase, and acetaldehyde is converted to acetic acid by acetaldehyde dehydrogenase (ALDH), and finally oxidized to CO by the tricarboxylic acid cycle 2 and H 2 O. Because the metabolic rate of ethanol mainly depends on the activity of metabolic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 黄春黄青春伍万兵李大萍陈纹锐
Owner SICHUAN TONGSHENG BIOTECH
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