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稳定性指示RP-HPLC方法的开发和验证,用于量化KetorolacTromethamine相关的杂质,在平板电脑固体口服剂量形式

Prasanna Kumar Lankalapalli¹, Naveen Maddukuri², Ashok Morsu³

¹Visual Technologies LLC, Plano, Texas, USA.

Biomedical chromatography : BMC

|June 27, 2025

概括

一种新的HPLC方法可以准确地确定KetorolacTromethamine片中的杂质. 这种验证的技术对于药物配方的质量控制和稳定性研究至关重要.

科学领域:

分析化学分析化学
药品分析药品分析

背景情况:

凯托洛拉克 (Ketorolac Tromethamine) 是一种广泛使用的非类固醇抗炎药物 (NSAID).
确保制药配方的纯度和稳定性对于患者安全和药物疗效至关重要.

研究的目的:

开发和验证一个梯度逆相高性能液态染色学 (HPLC) 方法.
为了确定KetorolacTromethamine片剂配方中的杂质.
评估药物在各种压力条件下的稳定性.

主要方法:

使用了梯度逆相HPLC系统与AgilentZorbax SB C8柱.
采用了酸缓冲器的移动相和甲醇/四基混合物.
保持柱体温度在40°C,流量为1.0mL/min,紫外线检测在254nm.
根据国际协调理事会 (ICH) 的指导方针验证了该方法.

主要成果:

该方法表现出高特异性和线性 (相关系数>0.999) 在0.201-6.445μg/mL范围内.
实现了高精度,超过97%的杂质的确定.
压力研究揭示了对基本,光解和氧化条件的敏感性.

结论:

开发的HPLC方法是特定的,线性的,准确的,精确的和强大的.
这种方法适合用于常规质量控制和稳定性指示研究的Ketorolac甲胺片.
了解药物降解途径对于配方开发和储存建议至关重要.

关键词:

在HPLC中使用HPLC.凯托洛拉克甲胺 (KTR)在 PDA 和 PDA 之间.开发方法开发方法的方法.验证验证的时间

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