A method for detecting the content of chlorpheniramine maleate in compound amiphenazone granules

By using acetonitrile-water mixed solvent and specific HPLC conditions, the problem of inaccurate determination of chlorpheniramine maleate content in compound acetaminophen granules was solved, achieving higher detection accuracy and quality control, and simplifying the operation process.

CN122409905APending Publication Date: 2026-07-17HEBEI CHANGTIAN PHARM CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
HEBEI CHANGTIAN PHARM CO LTD
Filing Date
2026-05-13
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

In the existing technology, the method for determining the content of chlorpheniramine maleate in compound acetaminophen and chlorpheniramine granules has the problem of incomplete extraction, which leads to the test results being significantly lower than the actual content and cannot accurately reflect the quality of the drug.

Method used

An acetonitrile-water (3:7, v/v) mixed solvent was used instead of pure acetonitrile as the solvent for the test sample to ensure complete dissolution of sucrose and chlorpheniramine maleate. An HPLC detection method using octadecylsilane-bonded silica gel as the packing material, combined with a specific mobile phase and detection wavelength, was used to achieve accurate extraction and detection of the active ingredients.

Benefits of technology

It improves the accuracy and reliability of test results, making the measured results close to the true content, with a recovery rate of 99.1%-99.8%, simplifies the operation steps, and enhances the level of quality control.

✦ Generated by Eureka AI based on patent content.

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Abstract

本发明公开了一种复方氨酚那敏颗粒中马来酸氯苯那敏含量的检测方法及应用。所述方法的核心是采用乙腈‑水(3:7)作为溶剂制备供试品溶液,解决了原质量标准中因使用纯乙腈导致蔗糖不溶、活性成分提取不完全而造成的含量测定结果偏低问题。该方法经验证,专属性强、精密度高、准确度好、线性关系良好且耐用性优异。本发明能更真实、有效地控制复方氨酚那敏颗粒的产品质量,保障药品疗效与安全。
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