Method for separating relevant substances of hydrochloric acid palonosetron injection by virtue of reversion phase chromatography

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...

AI Technical Summary

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

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