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开发和验证 HPLC 方法,用于对硫酸特尔布他林口服糖的杂质分析

Renming Yang¹, Qin Zeng¹, Likai Yang¹

¹Sichuan Aupone GOOD Pharmaceutical Co., Ltd., Baicao Road No 990, Hi-Tech Industrial Development Zone, Chengdu 610097, China.

Journal of chromatographic science

|December 29, 2025

概括

一种新的高性能液态色谱法可靠地识别了terbutaline硫酸盐口服糖中的杂质. 这种经过验证的方法通过稳定性测试和常规质量控制来确保药物的质量和安全性.

科学领域:

分析化学分析化学
药品分析药品分析

背景情况:

甲酸是一种儿科支气管扩展剂.
识别与过程和降解相关的杂质对于药物安全至关重要.

研究的目的:

开发和验证一种新的,可靠的高性能液态染色学 (HPLC) 方法.
为了识别terbutaline硫酸盐口服糖中与工艺和降解相关的杂质.

主要方法:

使用Inertsil ODS-3列与缓冲器和酸移动相进行HPLC分离.
在1.0毫升/分钟流速,30°C柱体温度下进行线性梯度化.
在各种压力条件下 (酸性,性,氧化,热性,光分解性) 的强制降解研究.

主要成果:

该方法表现出良好的线性 (确定系数>0.999) 和恢复率 (95%-105%).
光分解降解产生了Imp-B和三个与furfural相关的杂质.
该HPLC方法是稳定性指示和根据ICH指南进行验证.

结论:

经过验证的HPLC方法适用于常规质量控制的三甲酸口服糖.
这种方法确保了关键杂质的识别和量化,支持药物的安全性和有效性.

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Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...