Method for simultaneously determining four optical isomers of palonosetron hydrochloride

Abstract

The invention discloses a method for simultaneously determining four optical isomers of palonosetron hydrochloride. The four optical isomers are S.S, S.R, R.S, R.R respectively; and the method is characterized by comprising the following step of splitting the optical isomers of the palonosetron hydrochloride by using efficient liquid chromatography, wherein an OD-H chiral chromatographic column is included, and a mobile phase consists of acetonitrile, isopropanol and diethylamine in a volume ratio of (82-92): (18-8): (0.1-0.2), and the column temperature is 30 to 40 DEG C. A flow rate in the efficient liquid chromatography is 0.3 to 1.2 ml / min. The detection wavelength in the efficient liquid chromatography is 220nm. The method is simple, convenient and practical. The purpose of simultaneously determining and separating the four optical isomers can be rapidly achieved, a basis is provided for quality control of palonosetron hydrochloride raw materials and preparations, and the quality control of a new medicine is facilitated.

Description

technical field [0001] The invention relates to a method for separating and measuring optical isomers of palonosetron hydrochloride, in particular to a method for simultaneously measuring four optical isomers of palonosetron hydrochloride. Background technique [0002] Palonosetron hydrochloride (Palonosetron) is a highly selective 5-HT receptor antagonist (see the figure below for the structural formula, C 19 h 24 N 2 O·HCL), which can block the excitation of presynaptic 5-HT receptors in the peripheral neurons of the vomiting reflex center, and reduce the incidence of vomiting and nausea. The drug is currently in clinical use. [0003] The structural formula is: [0004] [0005] Palonosetron hydrochloride exerts its pharmacological effects in the SS configuration, and its isomers RR, RS, and SR have no biological effects. In the preparation process and sample preservation, it is very important to monitor its isomers, so as to understand the interference with the ma...

AI Technical Summary

Problems solved by technology

Bai Jiangtao disclosed a method for separating four isomers in the Chinese patent application [Application No. 200710074410.0], which has made great progress. However, in the actual test operation, this method is to adjust the temperature twice, that is, to inject Twice, and the separation is relatively complicated and cumbersome, and each time the chromatographic peak comes out is 3 components, not 4 components, the effect of one separation is not achieved

[0007] Based on the above, on the one hand, the separation and determination of the four isomers of palonosetron hydrochloride is very important; According to the literature, there is no report of an analytical method that achieves chromatographic separation at one time

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