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Lenalidomide enantiomer supercritical fluid chromatographic separation method

A supercritical fluid, enantiomer technology, applied in the field of chiral chromatographic separation, to achieve the effect of good separation effect and short separation time

Active Publication Date: 2018-02-16
GUANGDONG YANJIE PHARMA TECH CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there is no research report on the chiral separation and analysis of lenalidomide by supercritical fluid chromatography

Method used

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  • Lenalidomide enantiomer supercritical fluid chromatographic separation method
  • Lenalidomide enantiomer supercritical fluid chromatographic separation method
  • Lenalidomide enantiomer supercritical fluid chromatographic separation method

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Embodiment 1~12

[0029] The supercritical fluid chromatography separation method of embodiment 1~12 lenalidomide enantiomer

[0030] In the supercritical fluid chromatographic separation method of embodiment 1~12, the chromatograph that selects is Waters Acquity ultra-efficient converging chromatographic system (Ultra Performance Convergence Chromatography, UPC 2 ), the chromatographic column size is 150 mm×4.6 mm, and the mobile phase flow rate is 2.5 mL min -1 , the concentration of lenalidomide is 0.5 mg·mL -1 , the injection volume was 10 μL, and the detection wavelength was 220 nm.

[0031] Table 1 shows the remaining relevant conditions and corresponding separation results selected by the supercritical fluid chromatography separation method of lenalidomide enantiomers in Examples 1-12. Among them, Enantiopak AD represents the chiral stationary phase of amylose coated with three (3,5-dimethylphenylcarbamoylated) on the surface of silica gel; Formylated) amylose chiral stationary phase;...

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Abstract

The present invention relates to a lenalidomide enantiomer supercritical fluid chromatographic separation method, which comprises: dissolving a lenalidomide sample in a lower alcohol, and carrying outchiral analysis separation at a chiral stationary phase by using a supercritical fluid chromatography method, wherein the mobile phase is the mixture of supercritical carbon dioxide and a lower alcohol, the lower alcohol is methanol or ethanol, a volume ratio of the supercritical carbon dioxide to the lower alcohol in the mobile phase is 60-75:40-25, and the chiral stationary phase is one selected from a silica gel surface coated or bonded tris(3,5-dimethylphenylcarbamylated)amylose chiral stationary phase, a silica gel surface bonded 4-chlorophenylcarbamylated-beta-cyclodextrin chiral stationary phase, and a silica gel surface bonded 3,5-dimethylphenylcarbamylated-beta-cyclodextrin chiral stationary phase. According to the present invention, with the supercritical fluid chromatographic separation method, the chiral chromatographic separation of the lenalidomide enantiomer can be well achieved, and under the preferred condition, the resolution of the lenalidomide enantiomer is 5.05.

Description

technical field [0001] The invention belongs to the technical field of chiral chromatographic separation, and more specifically relates to a supercritical fluid chromatographic separation method for enantiomers of lenalidomide. Background technique [0002] Supercritical fluid chromatography (SFC) is a separation technique that uses supercritical fluid as the mobile phase and a solid adsorbent or a polymer bonded to the carrier as the stationary phase [Journal of Chromatography A, 2016, 1467:33- 55]. Compared with HPLC, SFC analysis and separation has significant advantages such as faster speed, shorter analysis time, and higher separation efficiency; at the same time, the solubility of samples in supercritical fluid is significantly increased, and the consumption of organic solvents is greatly reduced. Supercritical fluid chromatography preparation technology It is regarded as a green preparation process and has attracted great attention of researchers in the field of sepa...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 章伟光严逸伦范军赖烨才阮丽君
Owner GUANGDONG YANJIE PHARMA TECH CO LTD
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