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一种新的高性能液态染色法用于珀的确定和在化品和药品中的应用:开发和验证

Martin Lalić¹, Ana Soldić¹, Zdenka Lalić¹

¹Apipharma d.o.o., Pharmaceutical-Food, Cosmetic Industry and Trade, J. Kavanjina 26, 10090 Zagreb, Croatia.

Molecules (Basel, Switzerland)

|September 28, 2024

概括

一种新的高性能液态色谱 (HPLC) 方法准确地量化了化品和药品中的. 这种经过验证的方法确保了全球各种产品类型的可靠分析.

科学领域:

分析化学分析化学
药品分析药品分析
化品科学化品科学

背景情况:

坎佛是制药和化品中的常见成分.
准确量化坎对于质量控制和监管合规至关重要.
现有的分析方法可能缺乏对各种产品矩阵的敏感性或适用性.

研究的目的:

开发和验证一种新的高性能液态染色学 (HPLC) 方法来确定坎佛.
建立一个可靠的分析工具,用于在各种化品和制药配方中量化.
确保该方法符合国际验证指南 (ICH Q2 (R2)).

主要方法:

高性能液体色谱 (HPLC) 使用4-N,N-二甲基亚胺甲作为内部标准.
使用特定移动相组合的Symmetry® C18柱进行染色分离.
根据ICH Q2 (R2) 准则验证方法,评估选择性,线性,LOD,LOQ,准确性和精度.

主要成果:

开发的HPLC方法表现出优异的选择性,线性 (0.10-3.00 mg/mL) 和准确性 (置信区间<0.05%).
通过0.028 mg/mL的检测极限 (LOD) 和0.085 mg/mL的量化极限 (LOQ) 证实了灵敏度.
实现了高可重复性 (峰值面积比=0.39-1.97) 和中等精度 (峰值面积比=0.40-1.98).

结论:

新的HPLC方法为坎佛的量化提供了一个强大的和验证的方法.
该方法适用于分析各种化品和制药产品,包括凝,药膏和奶油.
这种分析技术通过覆盖全球立法规定的要求度范围来支持监管合规.

关键词:

坎花是一种花.爸爸爸爸爸是什么意思在HPLC中使用HPLC.内部标准是内部的标准.

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