A HPLC method for separating and analyzing related substances of levonidazole phosphate or its medicinal salt
A technology for ornidazole phosphate and related substances, applied in the field of high performance liquid phase analysis, can solve problems such as difficulty in effective separation
Active Publication Date: 2022-06-03
HC SYNTHETIC PHARMA CO LTD
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Problems solved by technology
[0008] From the structural investigation of the above impurities, some impurities are very similar to levonidazole phosphate or its pharmaceutical salt structure, and from the perspective of polarity, some impurities are very similar to levonidazole phosphate or its pharmaceutical salt. Therefore, it is very difficult to completely and effectively separate the above-mentioned impurities under the same chromatographic conditions, which makes it necessary to find a chromatogram that not only requires the effective separation of similar structure impurities but also takes into account the effective detection of weak polar impurities. condition becomes necessary
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Abstract
The method discloses an HPLC method for separating and analyzing related substances of levonidazole phosphate or its medicinal salt, using high-performance liquid chromatography, using C18, phenyl column, and cyano column as chromatographic columns, and buffer solution (pH Value 2-9) and an organic solvent to form a mobile phase in a certain proportion, this method can quickly, effectively and accurately separate and analyze the related substances of levo-ornidazole phosphate or its pharmaceutically acceptable salt.
Description
A kind of HPLC for separation and analysis of levornidazole phosphate or its medicinal salt related substances method technical field The present invention relates to a kind of high-efficiency liquid phase analysis method, specifically a kind of levornidazole phosphate or its medicinal salt Determination of separation and analysis of related substances. Background technique Levo-ornidazole phosphate or its pharmaceutically acceptable salt is the prodrug of levoornidazole, levoornidazole phosphate or its pharmaceutically acceptable salt After entering the body, it can be metabolized to levornidazole through the action of alkaline phosphatase, thereby exerting its medicinal effect. Levoornidazole is a A broad-spectrum triazole antifungal drug with the following indications: for the treatment of Bacteroides fragilis, Bacteroides, Bacteroides polymorpha, Bacteroides vulgaris, Clostridium, Eubacterium, Peptococcus and Peptostreptococcus, Helicobacter pylori, A variet...
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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027Y02A50/30
Inventor 陆华龙戚苏民马涛
Owner HC SYNTHETIC PHARMA CO LTD