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Method for detecting content of impurity 6-formylpterin in folic acid

A quantitative detection method and formylpterin technology, applied in the field of medicine, can solve problems such as low content and inability to detect, and achieve the effects of high sensitivity, high accuracy, and improved quality and drug safety.

Active Publication Date: 2021-07-16
北京斯利安药业有限公司
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Problems solved by technology

However, due to the low content of 6-formylpterin and pterin 6-carboxylic acid impurities in folic acid, they cannot be detected by conventional high-performance liquid chromatography (HPLC) and combined with UV detection.
Moreover, the chemical structure and physical and chemical properties of 6-formylpterin and pterin 6-carboxylic acid are close, and 6-formylpterin will also convert to pterin 6-carboxylic acid under certain conditions, resulting in no current An HPLC detection method for the separation of trace impurities 6-formylpterin and pterin 6-carboxylic acid in folic acid and the simultaneous quantitative detection of them

Method used

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  • Method for detecting content of impurity 6-formylpterin in folic acid
  • Method for detecting content of impurity 6-formylpterin in folic acid
  • Method for detecting content of impurity 6-formylpterin in folic acid

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Embodiment

[0031] 1. Main instruments and reagents

[0032] (1) Instrument: high-performance liquid chromatography instrument: Agilent 1200 Series, equipped with a fluorescence detector, and the operating software of the liquid chromatography instrument is ChemStation software (RevB.04.01SP1) of Agilent Company.

[0033] (2) Reagents: ultrapure water, methanol (chromatographically pure), phosphoric acid (chromatographically pure).

[0034] 2. Experimental method

[0035] (1) Chromatographic conditions:

[0036] Chromatographic column: Agilent SB-CN column, 4.6×250mm, 5μm; flow rate: 1.0mL / min; column temperature: 35℃; injection volume: 35μL; mobile phase A: methanol-water containing 0.2% phosphoric acid=20:80 ; Mobile phase B: methanol-0.2% phosphoric acid water=45:55.

[0037] See Table 1 for gradient elution conditions.

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Abstract

The invention provides a method for detecting the content of an impurity 6-formylpterin in folic acid. According to the method, Agi 1 entSB-CN is taken as a chromatographic column, after high performance liquid chromatography (HPLC) separation, a fluorescence detector is adopted to carry out qualitative and quantitative detection on the impurity 6-formylpterin in folic acid, and methodological verification is carried out. Experiments prove that the method can realize synchronous quantitative detection of trace photosensitive impurities 6-formylpterin and pterin 6-carboxylic acid in folic acid, and has the advantages of strong specificity, rapidness, high sensitivity, high accuracy and the like. The method for synchronously and quantitatively detecting the trace photosensitive impurities 6-formylpterin and pterin 6-carboxylic acid in the folic acid is established for the first time, and the quality control on the folic acid is facilitated, so that the quality and the medication safety of the folic acid bulk drug are improved.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a method for detecting the content of impurity 6-formylpterin in folic acid. In particular, it relates to a simultaneous quantitative detection method for trace photosensitive impurities 6-formylpterin and pterin 6-carboxylic acid in folic acid. Background technique [0002] Folic acid is a basic variety of vitamins, a substance necessary for the growth and reproduction of body cells, and plays an important role in the division and growth of cells and the synthesis of nucleic acids, amino acids, and proteins. The lack of folic acid in the human body can lead to abnormal red blood cells, increase of immature cells, anemia and leukopenia; lack of folic acid in pregnant women may lead to low birth weight, cleft lip and palate, heart defects, etc. [0003] Folic acid is extremely unstable and is easily oxidized by ultraviolet light and high temperature. When exposed to ultraviolet ra...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N2030/324
Inventor 孙圆丽杨卓理
Owner 北京斯利安药业有限公司
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