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A method for separating related substances of palonosetron hydrochloride injection by reverse phase chromatography

A technology of palonosetron and a separation method, which is applied in the field of reversed-phase high performance liquid chromatography for separating related substances of palonosetron hydrochloride injection, and can solve the problems of uncomfortable practical operation, damage to instruments and chromatographic columns, and failure to achieve one-time separation. and other problems, to achieve the effect of simple and convenient method, high sensitivity and good reproducibility

Active Publication Date: 2019-11-22
HANGZHOU XINBOSI BIOMEDICAL CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Chinese patent CN104764840A discloses the separation method of impurity A, diastereoisomer, and enantiomer, but does not involve impurity B, E, and does not achieve the effect of one-time separation, and in this method, ion pair reagent is used as flow The phase is run with a gradient, and the general ion-pairing reagent has irreversible damage to the instrument and chromatographic column, which is not suitable for practical operation
[0005] Therefore the prior art does not solve the problem that the impurity of Palonosetron Hydrochloride Injection is difficult to detect and separate, so research and development of a kind of analytical method for quickly and effectively separating the above-mentioned specific impurities in Palonosetron Hydrochloride Injection will affect the quality of pharmaceutical products. control is very important

Method used

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  • A method for separating related substances of palonosetron hydrochloride injection by reverse phase chromatography
  • A method for separating related substances of palonosetron hydrochloride injection by reverse phase chromatography
  • A method for separating related substances of palonosetron hydrochloride injection by reverse phase chromatography

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Embodiment 1

[0025] 1. Instruments and reagents:

[0026] Agilent 1260 liquid chromatograph equipped with G1314F ultraviolet detector and HPLC chromatographic workstation equipped with analytical instruments. Acetonitrile (chromatographic grade), methanol (chromatographic grade), diethylamine (analytical grade), glacial acetic acid (analytical grade), purified water.

[0027] 2. Chromatographic conditions:

[0028] Chromatographic column: CHIROBIOTIC T column (4.6×250mm, 5.0μm)

[0029] Detection wavelength: 238nm

[0030] Column temperature: 40°C

[0031] Flow rate: 1.0ml / min

[0032] Injection volume: 100μl

[0033] Mobile phase: mobile phase A: mobile phase B=40:60, where mobile phase A is methanol:acetonitrile=90:10, mobile phase B is 0.5% diethylamine aqueous solution (adjust pH to 5.0 with glacial acetic acid).

[0034] Diluent: mobile phase

[0035] 3. Solution Preparation

[0036] To prepare a system suitability solution:

[0037] (1) Impurity A solution: Weigh about 25mg ...

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Abstract

The invention relates to a high performance liquid chromatography for reverse-phase separation of a hydrochloric acid palonosetron injection and specific impurities of the injection. According to the chromatography, a macrocyclic glycopeptides chiral column is adopted, in which a volume ratio of a flow phase (a ratio of methanol to acetonitrile is 90 to 10) to 0.5% diethylamine water solution is (40 to 60)-(50 to 50), a detection wavelength is 238nm, a column temperature is 35-40 DEG C, and a flow speed is 0.8ml / min-1.2ml / min. By virtue of the chromatography, the specific impurities A, B, E, enantiomers and diastereoisomers collected in America pharmacopeia USP39 can be completely separated; and furthermore, the chromatography is simple, accurate and high in sensitivity, and can be used for detecting relevant substances of the hydrochloric acid palonosetron injection.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for separating related substances of palonosetron hydrochloride injection by reverse-phase high-performance liquid chromatography. Background technique [0002] Palonosetron Hydrochloride (Palonosetron Hydrochloride), trade name: Aloxi, chemical name 2-(1-azabicyclo[2,2,2]oct-3S-yl-2,3,3aS,4,5 ,6-Hexahydro-1H-benzo[de]isoquinolin-1-one hydrochloride is a highly efficient, selective and competitive 5-hydroxytryptamine 3 receptor antagonist developed by Helsinn, Switzerland. FDA-approved for the prevention of acute and delayed nausea and vomiting associated with initiation and repeat courses of moderately and highly emetogenic chemotherapy (CT), and the only option for delayed CINA (chemotherapy-induced nausea and vomiting) 5-hydroxytryptamine receptor blocker. The structural formula of palonosetron hydrochloride is as follows: [0003] [0004] Accordi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 江佳佳周卫枫郑春燕何彩霞沈凤梅刘艳华
Owner HANGZHOU XINBOSI BIOMEDICAL CO LTD
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