Method for detecting p-chlorobenzhydryl piperazine in levocetirizine hydrochloride particles
The separation and determination of impurity A in levocetirizine hydrochloride particles by high performance liquid chromatography solved the problem of difficulty in detection, and achieved improvement in quality control and guarantee of pharmaceutical safety.
CN120064494APending Publication Date: 2025-05-30HAINAN HONZ PHARMA CO LTD
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Patent Information
- Application Number
- CN202510235397.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-02-28
- Publication Date
- 2025-05-30
AI Technical Summary
Technical Problem
The detection of impurity A (p-chlorodiphenylpiperazine) in levocetirizine hydrochloride particles is difficult to detect, affecting the quality control of the preparation.
Method used
High performance liquid chromatography was used to separate and measure the separation and determination of levocetirizine hydrochloride and impurity A from the octadecylsilane-bonded silica gel chromatography column using a mixed solution of phosphoric acid and acetonitrile-methanol solution as the mobile phase.
Benefits of technology
The accurate and reliable detection of impurity A in levocetirizine hydrochloride particles is achieved, the quality control level of the preparation is improved, and the safety of pharmaceuticals is ensured.
✦ Generated by Eureka AI based on patent content.
Abstract
The invention provides a method for detecting parachlorobenzhydryl piperazine in levocetirizine hydrochloride particles. The method comprises the following steps: determining related substances in the levocetirizine hydrochloride particles by adopting a high performance liquid chromatography, a chromatographic column in the method is a chromatographic column taking octadecylsilane chemically bonded silica as a filling agent; a mobile phase is a mixed solution of a mobile phase A and a mobile phase B, a phosphoric acid aqueous solution is taken as the mobile phase A, an acetonitrile-methanol solution is taken as the mobile phase B, linear gradient elution is adopted, the concentration of the mobile phase A is adjusted within the range of 75% v / v-20% v / v, the concentration of the mobile phase B is adjusted within the range of 80% v / v-25% v / v, and the elution time is 60-70 min. The levocetirizine hydrochloride and related substances (impurity A: parachlorobenzhydryl piperazine) can be accurately and reliably separated and determined well, so that the quality control of the levocetirizine hydrochloride particles is effectively realized, and the pharmaceutical safety is improved.
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