A method for detecting residual solvents in moxifloxacin hydrochloride bulk drug

This study utilizes headspace gas chromatography (HGC) to achieve rapid and accurate detection of residual amounts of 10 solvents—methanol, petroleum ether, ethanol, isopropanol, acetonitrile, dichloromethane, ethyl acetate, methyl isobutyl ketone, toluene, and DMF—in moxifloxacin hydrochloride raw material. This method solves the problem of existing technologies being unable to simultaneously detect these solvent residues. It enables the detection of residual amounts of methanol, petroleum ether, ethanol, isopropanol, acetonitrile, ethyl acetate, toluene, and N,N-dimethylformamide in the production process of moxifloxacin hydrochloride, which is not applicable to existing technologies in the production process of moxifloxacin hydrochloride.

CN122409940APending Publication Date: 2026-07-17SHANGHAI HAOHAI BIOLOGICAL TECH +2
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Patent Information

Application Number
CN201911337272.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2019-12-23
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

Existing technologies cannot simultaneously and rapidly detect the residual amounts of several solvents, including methanol, petroleum ether, ethanol, isopropanol, acetonitrile, dichloromethane, ethyl acetate, methyl isobutyl ketone, toluene, and N,N-dimethylformamide, in moxifloxacin hydrochloride raw materials. Furthermore, existing technologies are not applicable to methods for detecting the residual amounts of these 10 solvents in moxifloxacin hydrochloride raw materials, nor are they applicable to methods for detecting the residual amounts of toluene and N,N-dimethylformamide in the production process of moxifloxacin hydrochloride.

Method used

A headspace gas chromatography method was adopted to detect the residues of toluene and N,N-dimethylformamide in the production process of moxifloxacin hydrochloride. Existing technologies are not applicable to the detection of toluene and N,N-dimethylformamide residues in the production process of moxifloxacin hydrochloride.

Benefits of technology

This invention enables the detection of several residues, including methanol, petroleum ether, ethanol, isopropanol, acetonitrile, ethyl acetate, toluene, and N,N-dimethylformamide, in the production process of moxifloxacin hydrochloride. Existing technologies are not applicable to methods for detecting the residues of toluene and N,N-dimethylformamide in the production process of moxifloxacin hydrochloride.

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Abstract

本发明涉及一种盐酸莫西沙星原料药中残留溶剂的检测方法,以AgilentDB‑23毛细管柱为色谱柱、以苯甲醇作为溶剂,采用顶空气相色谱法同时测定可能存在的甲醇、石油醚、乙醇、异丙醇、乙腈、二氯甲烷、乙酸乙酯、甲基异丁基酮、甲苯和DMF这10中有机溶剂的残留量,检测过程不受温度影响,样品处理简单方便,从检测限、定量限、线性、稳定性、加样回收率等方法学的考察方面,检测结果准确可靠,以上10种有机溶剂与苯甲醇的分离效果好,均符合定量测定的要求,适于工业化生产使用,有较大的应用价值。
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