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Method for detecting D-calcium pantothenate impurities

A detection method and technology of calcium pantothenate, applied in the field of chromatographic columns, can solve problems such as inability to specify the content of impurities, and achieve the effects of short detection time, simple processing method and convenient operation.

Inactive Publication Date: 2019-08-02
内蒙古精晶生物科技有限公司
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  • Abstract
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  • Claims
  • Application Information

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Problems solved by technology

[0004] Aiming at the technical problem that the content of impurities cannot be specified in the prior art, the present invention provides a method for detecting impurities in calcium D-pantothenate

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  • Method for detecting D-calcium pantothenate impurities

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Embodiment 1

[0028] The embodiment of the present invention provides a method for detecting calcium D-pantothenate impurities. The high-performance liquid chromatograph used is Agilent 1100, and the chromatographic column is an octadecylsilane bonded silica gel column (5 μm, 4.6×250mm). The volume is 20 μl (quantitative loop). Including the following steps:

[0029] 1. Standard solution preparation:

[0030] 4mg / L solution preparation: Precisely measure 40mg each of impurity 1 (β-alanine), impurity 2 (D-pantothenic acid lactone), and impurity 3 (sodium pantothenate) into a 100ml volumetric flask, add mobile phase to dissolve , Dilute to the mark, take 1ml to a 100ml volumetric flask, add mobile phase to make up to the mark, and you get it.

[0031] 10mg / L solution preparation: Precisely measure 40mg each of impurity 1 (β-alanine), impurity 2 (D-pantothenic acid lactone), and impurity 3 (sodium pantothenate) into a 100ml volumetric flask, add mobile phase to dissolve , Dilute to the mark...

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Abstract

The invention belongs to the technical field of chromatographic columns, and particularly relates to a method for detecting D-calcium pantothenate impurities. The impurities comprise beta-alanine, D-pantolactone and sodium pantothenate. The detection method is a high performance liquid chromatography method; a flowing phase is a mixed solution of a phosphate buffer solution and acetonitrile with avolume ratio of 8.5-9.5 : 1. The impurities are key impurities affecting the stability of finished D-calcium pantothenate; the high performance liquid chromatography method adopted by the method canenable a chromatographic peak of the D-calcium pantothenate and various impurity peaks to be well separated, and the content of the impurities in a to-be-detected sample can be accurately determined at the same time; and the method is high in detection sensitivity, low in detection limit and suitable for detection of the impurities in a production process of the D-calcium pantothenate.

Description

technical field [0001] The invention belongs to the technical field of chromatographic columns, and in particular relates to a method for detecting impurities of calcium D-pantothenate. Background technique [0002] Calcium D-pantothenate is mainly used in the prevention and treatment of calcium pantothenate deficiency (mainly manifested as malabsorption syndrome, tropical sprue, celiac disease, Crohn's disease, etc.) or the application of calcium pantothenate antagonists. It can also be used as an adjuvant therapy for vitamin B deficiency, peripheral neuritis, postoperative colic and other diseases (such as streptomycin poisoning, postoperative ileus, rheumatoid, etc.). [0003] At present, in the actual production of Calcium D-pantothenate, it is necessary to carry out sampling inspection on its intermediate products and finished products to understand the impurities. Most of the detection methods for impurities in D-calcium pantothenate in the prior art are detected by t...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/74G01N30/34
CPCG01N30/02G01N30/34G01N30/74G01N2030/027
Inventor 李素霞李海松张亮孔娟娟牛聚敏薛海英
Owner 内蒙古精晶生物科技有限公司
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