Method for analyzing high performance liquid chromatography of methanesulfonic amine ginkgolide B

A high-performance liquid chromatography, ginkgolide technology, applied in the direction of analysis of materials, material separation, measuring devices, etc.

Active Publication Date: 2010-03-31
JIANGSU CAREFREE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The quality control of the innovative compound mesylate am

Method used

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  • Method for analyzing high performance liquid chromatography of methanesulfonic amine ginkgolide B
  • Method for analyzing high performance liquid chromatography of methanesulfonic amine ginkgolide B
  • Method for analyzing high performance liquid chromatography of methanesulfonic amine ginkgolide B

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The identification and content determination of embodiment 1 mesylate amine ginkgolide B crude drug

[0029] Get need testing product and mesylate amine ginkgolide B reference substance appropriate amount, be mixed with water respectively the solution of 1.0mg / ml, for testing; To contain 5mmol / L sodium butanesulfonate and 20mmol / L sodium dihydrogen phosphate ( 1mol / L sodium hydroxide solution to adjust the pH to 7.8) aqueous solution-acetonitrile (volume ratio: 49 / 51) as the mobile phase; the chromatographic column is a C18 column; the column temperature is 25°C; the detection wavelength is 210nm; the flow rate is 1.0ml / min .

[0030] According to the external standard method, the content of the test product is calculated by the peak area of ​​the main component; the identification is made according to whether the retention time of the main peak of the test product solution and the reference solution is consistent.

[0031] Identification and content determination resu...

Embodiment 2

[0034] Identification and assay of embodiment 2 mesylate amine ginkgolide B sheet

[0035] Get an appropriate amount of ammonium ginkgolide mesylate B reference substance, dissolve with acetonitrile and be formulated with a solution of 1.0 mg / ml, as the reference substance solution; get an appropriate amount of test sample fine powder, dissolve the principal agent with acetonitrile and quantitatively dilute to formaldehyde-containing The solution of sulfonate amine ginkgolide B1.0mg / ml filters, and gets the continued filtrate as need testing solution; With the aqueous solution-acetonitrile (volume ratio: 45 / 55) as the mobile phase; the chromatographic column is a C18 column; the column temperature is 25°C; the detection wavelength is 205nm; the flow rate is 0.8ml / min.

[0036] According to the external standard method, the content of the test product is calculated by the peak area of ​​the main component; the identification is made according to whether the retention time of th...

Embodiment 3

[0040] The identification and assay of embodiment 3 amine ginkgolide mesylate B for injection

[0041] Take 10mmol / L disodium hydrogen phosphate solution-methanol (volume ratio: 40 / 60) as the mobile phase; take an appropriate amount of ammonium ginkgolide mesylate B reference substance, dissolve it with the mobile phase and prepare a 1.0mg / ml solution, As reference substance solution; get need testing substance appropriate amount, dissolve and quantitatively dilute into the solution containing mesylate amine ginkgolide B1.0mg / ml with mobile phase, as need testing solution; Chromatographic column is C8 column; Column temperature 30 °C; detection wavelength is 215nm; flow rate is 1.2ml / min.

[0042] According to the external standard method, the content of the test product is calculated by the peak area of ​​the main component; the identification is made according to whether the retention time of the main peak of the test product solution and the reference solution is consistent...

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Abstract

The invention relates to a method for analyzing a high performance liquid chromatography of methanesulfonic amine ginkgolide B, comprising the following steps: using chromatographic columns with different polarities, adopting one or more organic solvents and aqueous-phase mixing liquid as a flowing phase, and under the detection conditions that the column temperature is 10-50 DEG C, the flow velocity of the flowing phase is 0.1-10ml/min, and the detection wavelength is 190-400nm, identifying bulk drugs and preparations of the methanesulfonic amine ginkgolide B, detecting relative matters and measuring the content by adopting an ultraviolet detector or a diode array detector so as to control the quality of the methanesulfonic amine ginkgolide B.

Description

technical field [0001] The invention relates to a high-performance liquid chromatography analysis method for amine ginkgolide mesylate B, which has good effect on the quality control of the raw material drug of the compound and its preparation, and its technical field belongs to the analysis method of medicine. Background technique [0002] Mesylate amine ginkgolide B is a mesylate salt, and its core part is an amino-containing molecule obtained after derivation and modification of ginkgolide B. Ginkgolide B (Ginkgolide B, GB) is a hexacyclic cage structure diterpenoid extracted from Ginkgo biloba, and it is the strongest platelet activating factor (PAF) antagonist found so far. Amino ginkgolide mesylate B is a semi-synthetic innovative compound with the molecular formula C 24 h 33 o 10 N·CH 4 o 3 S, the molecular weight is 591.63. The molecular structure is as follows: [0003] [0004] Amino ginkgolide mesylate B is a PAF-specific antagonist, which can inhibit th...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 秦引林
Owner JIANGSU CAREFREE PHARM CO LTD
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