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Method for separating and measuring palonosetron hydrochloride optical isomer

A technology of palonosetron and optical isomers, applied in the field of separation and determination of palonosetron hydrochloride optical isomers, to achieve the effect of controlling the internal quality

Inactive Publication Date: 2008-11-12
深圳万乐药业有限公司
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  • Abstract
  • Description
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  • Application Information

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Problems solved by technology

After the palonosetron hydrochloride raw material is prepared, it is necessary to implement quality monitoring and detection. Since there is no method for the detection of optical isomers in the palonosetron hydrochloride raw material, there is a lack of palonosetron hydrochloride raw material. Implement perfect quality control

Method used

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  • Method for separating and measuring palonosetron hydrochloride optical isomer
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  • Method for separating and measuring palonosetron hydrochloride optical isomer

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Embodiment Construction

[0016] 1. Instruments and reagents

[0017] 1.1 Instruments and reagents:

[0018] Instrument: Shimadzu 2010 high performance liquid chromatography, chromatographic grade n-hexane, ethanol (Merck), diethylamine (analytical grade).

[0019] Reagents: S.R, R.R, R.S type isomers, three batches of palonosetron hydrochloride raw materials PAL040601, PAL040602, PAL040603 (Shenzhen Wanle Pharmaceutical Co., Ltd.).

[0020] 1.2 Chromatographic conditions:

[0021] Chromatographic column: CHIRALPAK AD-H 5μ250mm×4.6mm (Jiangsu Hanbang Technology Co., Ltd.), with tris(3,5-dimethylphenylcarbamate) amylose as filler

[0022] Detector and detection wavelength: UV-220nm

[0023] Mobile phase: n-hexane: ethanol: diethylamine (92:8:0.4)

[0024] Flow rate: 0.6ml / min, injection volume: 20μl

[0025] Column temperature: 20°C (R.R, R.S, S.S) and 42°C (R.R, S.S, S.R)

[0026] 2. Solution Preparation

[0027] The test solution accurately weighed about 12.5 mg of palonosetron hydrochloride ra...

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Abstract

The invention discloses a separation and determination method of the optical isomer of Palonosetron HCl; the separation and determination method comprises the resolution of the optical isomer of the Palonosetron HCl by high performance liquid chromatography, wherein, amylose-three (3,5-xylyl methyl carbamate) is used as the filler by normal phase chromatographic columns, the volume ratio of mobile phase n-hexane: alcohol: diethylamine is 75-95: 5-25: 0.1-0.5, the column temperature for separating R. R isomer, R. S isomer and S. S isomer is 15 to 25 DEG C, while the column temperature for separating R. R isomer, S. S isomer and S. R isomer is 35 to 45 DEG C. The method of the invention provides an important basis for the quality monitoring of Palonosetron HCl material.

Description

technical field [0001] The invention relates to a method for separating and measuring the optical isomers of palonosetron hydrochloride, in particular to a method for separating the optical isomers of palonosetron hydrochloride by using high performance liquid chromatography. Background technique [0002] A molecule of a substance that does not overlap with its mirror image is called a chiral molecule. If two molecules are mirror images of each other, they are called enantiomers. Enantiomers have the same structure, but different configurations, so the enantiomers have the same specific optical rotation values, opposite directions, the same other physical properties, similar chemical properties, but different physiological properties. For compounds with a carbon chain as the backbone, when the four atoms or groups connected to the carbon atom are different, the carbon atom is called a chiral carbon atom. The number of isomers of compounds containing n chiral carbon atoms i...

Claims

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Application Information

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IPC IPC(8): G01N30/60G01N30/02
Inventor 柏江涛张汉利宝玉荣
Owner 深圳万乐药业有限公司
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