A method for detecting N-hydroxy derivatives by liquid chromatography-mass spectrometry

High-performance liquid chromatography-mass spectrometry (HPLC-MS) using liquid chromatography-mass spectrometry (LC-MS) has solved the problem of detecting N-hydroxy derivatives in active pharmaceutical ingredients (APIs), enabling rapid and accurate separation and quantitative analysis, and ensuring that the quality of APIs and formulations meets standards.

CN116465987BActive Publication Date: 2026-09-11HUBEI GUANGJI PHARM TECH CO LTD
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Patent Information

Application Number
CN202310212499.1
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2023-03-07
Publication Date
2026-09-11
Estimated Expiration
2043-03-07

AI Technical Summary

Technical Problem

Current technologies lack rapid and accurate detection methods to analyze the presence and content of N-hydroxy derivatives in active pharmaceutical ingredients, which affects the quality control of synthesis and formulation processes.

Method used

The liquid chromatography-mass spectrometry (LC-MS) technique is used to achieve rapid separation and quantitative determination of N-hydroxy derivatives through specific solvent preparation, gradient elution programs and mass spectrometry conditions. This includes using methanol or acetonitrile as organic solvents, formic acid or trifluoroacetic acid as mobile phases, and combining appropriate chromatographic column, flow rate, voltage and temperature conditions.

Benefits of technology

It achieves efficient separation and high-sensitivity detection of N-hydroxy derivatives under the same chromatographic-mass spectrometry conditions, providing data support for quality control and ensuring that the quality of active pharmaceutical ingredients and formulations meets standards.

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Abstract

The present application belongs to the technical field of chemical analysis, and particularly relates to a method for detecting N-hydroxy derivatives by using liquid chromatography-mass spectrometry. First, a sample to be detected is dissolved in a mixed solution of an organic solvent and water to prepare a sample solution to be detected, and then the sample solution to be detected is injected into a liquid chromatography-mass spectrometer for detection. The types and contents of N-hydroxy derivatives contained in the sample to be detected are analyzed according to a chromatogram. The method has good elution and separation effects, high detection sensitivity and strong specificity, and can separate various N-hydroxy derivatives in the sample under the same chromatographic conditions and with high sensitivity. The N-hydroxy derivative impurities and their contents in the sample can be quickly, accurately and reliably detected. Through detection of N-hydroxy derivative related impurities in the crude drug and its preparation, data assistance and adjustment direction can be provided for quality control of the synthesis and preparation process, so as to effectively control the quality of the crude drug and its preparation.
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