Analysis method of impurity C, impurity D and enantiomer in palonosetron hydrochloride injection or bulk drug

A technology for palonosetron and enantiomers, which is applied in the field of analytical chemistry, can solve the problems of unsuitable detection of impurities C, D and enantiomers, and achieves the effect of reducing time and reagent costs

Inactive Publication Date: 2019-12-10
WUXI KAIFU PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The technical problem to be solved in the present invention is to overcome the USP PF41 (1) specific impurity method that palonosetron hydrochloride injection in the prior art is only suitable for detecting impurities A, B...

Method used

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  • Analysis method of impurity C, impurity D and enantiomer in palonosetron hydrochloride injection or bulk drug
  • Analysis method of impurity C, impurity D and enantiomer in palonosetron hydrochloride injection or bulk drug
  • Analysis method of impurity C, impurity D and enantiomer in palonosetron hydrochloride injection or bulk drug

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Embodiment

[0022] Take 5.0ml of palonosetron hydrochloride injection, put it in a 20ml test tube, add 2.0ml of 10mol / L sodium hydroxide solution, and shake for 1min to free the palonosetron hydrochloride. Then add 1.0ml of n-hexane, shake it, let it stand until the layers are separated (about 5min), and take the upper n-hexane phase as the test solution. Take an appropriate amount of impurity C, impurity D and enantiomer reference substance, add ethanol to dissolve and make a solution containing about 0.06mg per 1ml, as impurity stock solution. Take another appropriate amount of palonosetron hydrochloride reference substance and impurity stock solution, and dilute with mobile phase to make a solution containing about 0.24 mg of palonosetron and 1.2 μg of each isomer per 1 ml, as a system suitability solution. Measure according to high performance liquid chromatography (general rules 0512), use polysaccharide-coated chiral column, n-hexane-methanol-diethylamine (70:30:0.1) is mobile phase...

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Abstract

The invention discloses an analysis method of an impurity C, an impurity D and an enantiomer in the palonosetron hydrochloride injection or a bulk drug. According to the invention, the chromatographicconditions are optimized, a normal phase chromatographic column is adopted, and the normal phase HPLC systems are used to complete the separation of the impurity C, the impurity D and the enantiomer.By carrying out alkali treatment on a to-be-detected sample, the palonosetron hydrochloride is dissociated and is extracted by using normal hexane, the upper-layer n-hexane is taken as a sample solution for test, and the n-hexane-methanol-diethylamine (70: 30: 0.1) is used as a flowing phase, a polysaccharide coating chiral column is adopted for separation, and the detection wavelength is 240 nm,and finally the impurity C, the impurity D and the enantiomer are completely separated. According to the present invention, the separation degree is greater than 1.5, the analysis time is only 20 min, and the time and reagent cost are reduced.

Description

technical field [0001] The invention relates to the technical field of analytical chemistry, in particular to a method for analyzing impurity C, impurity D and enantiomers in palonosetron hydrochloride injection or palonosetron hydrochloride bulk drug. Background technique [0002] Palonosetron hydrochloride injection, the main ingredient is palonosetron hydrochloride, its chemical name is: (3aS)2-[(3S)-1-azabicyclo(2.2.2)oct-3S-yl] -2,3,3aS,4,5,6-Hexahydro-1H-benzo[de]isoquinolin-1-one hydrochloride. It is used to prevent acute nausea and vomiting caused by severe emetogenic chemotherapy and to prevent nausea and vomiting caused by moderate emetogenic chemotherapy. [0003] For Palonosetron Hydrochloride Injection, the existing detection conditions mainly refer to USP, and are inspected under the method for specific impurities in USP PF 41(1). However, the SP PF 41(1) specific impurity method has the following disadvantages: [0004] 1) Under the USP PF 41(1) specific im...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/027G01N2030/062
Inventor 刘骞
Owner WUXI KAIFU PHARMA
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