Method for analyzing the purity of N-p-aminobenzoyl-L-glutamic acid through liquid chromatography

A technology for p-aminobenzoyl and liquid chromatography analysis, which is applied in the field of liquid chromatography analysis of the purity of N-p-aminobenzoyl-L-glutamic acid, and can solve the problem that the medical effect of medicines cannot be guaranteed, and the purity and quality cannot be analyzed. and monitoring, the quality of folic acid cannot be guaranteed, etc., to achieve the effect of strong sample stability, high accuracy and precision of analysis results, and high accuracy and precision.

Inactive Publication Date: 2011-04-13
SHANGHAI NORMAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

As a result, when domestic and foreign enterprises provide raw materials for folic acid production to synthesize the intermediate, they have been unable to analyze and monitor its purity and quality; the quality of folic acid cannot be guaranteed, and the medical effect of the drug cannot be guaranteed

Method used

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  • Method for analyzing the purity of N-p-aminobenzoyl-L-glutamic acid through liquid chromatography
  • Method for analyzing the purity of N-p-aminobenzoyl-L-glutamic acid through liquid chromatography
  • Method for analyzing the purity of N-p-aminobenzoyl-L-glutamic acid through liquid chromatography

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Experimental program
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Embodiment 1

[0050] 1. Set the operating conditions of HPLC:

[0051] 1. Mobile phase: H 3 PO 4 -KH 2 PO 4 Buffer solution-methanol system, buffer solution / methanol volume ratio V 缓冲溶液 / V 甲醇 =80 / 20;

[0052] 2. The composition of the buffer solution is: drop concentrated phosphoric acid to 50mmol / L KH 2 PO 4In the aqueous solution, carefully adjust to the pH of the buffer solution = 3.7;

[0053] 3. Flow rate: 0.3mL / min;

[0054] 4. Ultraviolet detector, detection wavelength: 254nm;

[0055] 5. Chromatographic column: Agilent-Hypersil ODS (100×4.6mm, 5um);

[0056] 6. Waters 515 liquid chromatograph with Waters 2487 UV detector;

[0057] 7. Injection volume: 1-20μL.

[0058] 2. Prepare the solution:

[0059] 1. Preparation of internal standard solution: Accurately weigh 50mg of anhydrous p-aminobenzenesulfonic acid, place it in a 50mL volumetric flask, dissolve it with mobile phase and adjust the volume to the mark.

[0060] 2. Preparation of standard sample and sample soluti...

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Abstract

The invention relates to an analysis technology of pharmaceutical intermediates, in particular to a method for analyzing the purity of N-p-aminobenzoyl-L-glutamic acid through chromatography. No method for analyzing the purity of an N-p-aminobenzoyl-L-glutamic acid sample exits in the prior art so that the purity and the quality of the N-p-aminobenzoyl-L-glutamic acid sample can not be analyzed and monitored, thus the quality of a folic acid synthesized by using the N-p-aminobenzoyl-L-glutamic acid as a raw material can not be ensured, and medical effect can not be ensured. In the method of the invention, the purity of the N-p-aminobenzoyl-L-glutamic acid sample is analyzed with an internal standard curve method by adopting a common C18 column matching with an ultraviolet detector, taking an H3PO4-KH2PO4 buffer solution-methanol system as a mobile phase and adopting a sulfanilic acid as an internal standard substance, wherein the flow velocity of the mobile phase is set as 0.3 milliliter/minute. The method has the advantages of easily realized analysis conditions, high stability of the sample, good repeatability of an analysis result and high accuracy of the analysis result.

Description

technical field [0001] The present invention relates to the analysis technology of medicine intermediate, specifically a kind of liquid chromatography analysis method for the purity of N-p-aminobenzoyl-L-glutamic acid. Background technique [0002] N-p-aminobenzoyl-L-glutamic acid is an important intermediate in the synthesis of anti-anemia drug folic acid. The purity of N-para-aminobenzoyl-L-glutamic acid is of great significance to the quality and medical effect of folic acid. There is no method for analyzing the purity of N-p-aminobenzoyl-L-glutamic acid samples in the prior art, and no reports have been found after extensive consultation of domestic and foreign publications and retrieval of patent documents. As a result, when domestic and foreign enterprises provide raw materials for folic acid production to synthesize the intermediate, they have been unable to analyze and monitor its purity and quality; the quality of folic acid cannot be guaranteed, and the medical ef...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/26
Inventor 郭建宇
Owner SHANGHAI NORMAL UNIVERSITY
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