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A quality control method for the preparation process of high optical purity folic acid

A quality control method and optical purity technology, which can be used in measurement devices, scientific instruments, instruments, etc., can solve the problem of unreceived detection methods of folic acid optical isomers, and achieve high sensitivity, strong specificity and good reproducibility. Effect

Active Publication Date: 2018-03-27
北京斯利安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, the detection methods of folic acid optical isomers have not been included in the pharmacopoeias of the United States Pharmacopoeia (USP), the British Pharmacopoeia (BP), the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP) and the Chinese Pharmacopoeia (CP), and there is no relevant information about p-amino Literature reports and patent applications on the determination method of benzoyl-L-glutamic acid and folic acid optical isomers

Method used

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  • A quality control method for the preparation process of high optical purity folic acid
  • A quality control method for the preparation process of high optical purity folic acid
  • A quality control method for the preparation process of high optical purity folic acid

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Experimental program
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Effect test

Embodiment 1

[0023] 1.1 Chromatographic conditions

[0024] Instrument: Shimadzu LC-20AT high performance liquid chromatography

[0025] Chromatographic column: CHIRALPAK QN-AX (150mm×4.6mm, 5μm) chromatographic column

[0026] Mobile phase: methanol-glacial acetic acid-triethylamine (100:2:3)

[0027] Flow rate: 0.8ml / min

[0028] Detection wavelength: 280nm

[0029] Column temperature: 30°C

[0030] Injection volume: 20μl

[0031] 1.2 Sample preparation

[0032] 1.2.1 Positioning solution preparation

[0033] Take about 10 mg of p-aminobenzoyl-L-glutamic acid and 10 mg of p-aminobenzoyl-D-glutamic acid, weigh them accurately, put them in different 100ml measuring bottles, and dissolve them with about 1ml of methanol respectively, Then use the above-mentioned mobile phase to adjust the volume to the scale to obtain positioning solutions 1 and 2; take about 10 mg of folic acid and folic acid isomers, weigh them accurately, put them in different 100 ml measuring bottles, and use abou...

Embodiment 2

[0043] 2.1 Chromatographic conditions

[0044] Instrument: Shimadzu LC-20AT high performance liquid chromatography

[0045] Chromatographic column: CHIRALPAK CROWNPAK CR(+) (150mm×4.0mm, 5μm) chromatographic column

[0046] Mobile phase: methanol-0.1mol / L perchloric acid-diethylamine (10:90:5)

[0047] Flow rate: 2.0ml / min

[0048] Detection wavelength: 274nm

[0049] Column temperature: 15°C

[0050] Injection volume: 20μl

[0051] 2.2 Sample preparation

[0052] 2.2.1 Positioning solution preparation

[0053]Take about 10 mg of p-aminobenzoyl-L-glutamic acid and 10 mg of p-aminobenzoyl-D-glutamic acid, weigh them accurately, put them in different 100ml measuring bottles, and dissolve them with about 1ml of methanol respectively, Then use the above-mentioned mobile phase to make up the volume to the scale, and then get positioning solutions 1-2; take about 10 mg of folic acid and folic acid isomers, weigh them accurately, put them in different 100 ml measuring bottles,...

Embodiment 3

[0062] 3.1 Chromatographic conditions

[0063] Instrument: Shimadzu LC-20AT high performance liquid chromatography

[0064] Chromatographic column: CHIRALPAK AD-H (150mm×4.6mm, 5μm) chromatographic column

[0065] Mobile phase: isopropanol (containing 20% ​​ethanol)-glacial acetic acid-diethylamine (100:1:5) [equivalent to isopropanol:ethanol:glacial acetic acid:diethylamine=80:20:1:5] ;

[0066] Flow rate: 0.3ml / min

[0067] Detection wavelength: 290nm

[0068] Column temperature: 40°C

[0069] Injection volume: 10μl

[0070] 3.2 Sample preparation

[0071] 3.2.1 Positioning solution preparation

[0072] Take about 10 mg of each of p-aminobenzoyl-L-glutamic acid and p-aminobenzoyl-D-glutamic acid, accurately weigh them, put them in different 100ml measuring bottles, and dissolve them to the mark with the above mobile phase to obtain Positioning solutions 1-2; take about 10 mg of folic acid and folic acid isomers, weigh them accurately, put them in different 100 ml mea...

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PUM

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Abstract

The invention belongs to the technical field of drug analysis and quality control, and provides a quality control method used in the preparation process of folic acid with high optical purity. The invention has the characteristics of strong specificity, good separation, high sensitivity, strong operability and the like. By adopting the present invention to strictly control the optical purity of p-aminobenzoyl-L-glutamic acid, folic acid with an optical purity greater than 99.9% can be obtained, which is beneficial to the quality control in the whole folic acid raw material production process; meanwhile, under the quality control system , fewer side reactions, high optical purity of folic acid, and good stability, and can be used for quality control of the folic acid bulk drug preparation process.

Description

technical field [0001] The invention relates to a quality control method used in the preparation process of folic acid with high optical purity, belonging to the technical field of drug analysis and quality control. Background technique [0002] Folic acid, also known as pteroyl L-glutamic acid, is a water-soluble B vitamin. Folic acid is one of the indispensable nutrients for the human body. Supplementing folic acid preparations during pregnancy can effectively prevent birth defects such as neural tube defects in offspring. Secondly, folic acid also has the effects of preventing anemia, anti-atherosclerosis, preventing and treating cardiovascular and cerebrovascular diseases, anti-aging, preventing and treating gastrointestinal cancer, relieving diabetes, and reducing the incidence of osteoporotic fractures. [0003] There are many chemical synthesis methods for folic acid, but most of them obtain p-aminobenzoyl-L-glutamic acid (folate precursor) through various routes, an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 易斌安明榜张妮常坦然
Owner 北京斯利安药业有限公司