Abstract

The challenge of the present work concerned in benznidazole assay in two drug delivery systems (DDS) which are different in the solubility character and sample complexity using HPLC−diode array detector (DAD) method. The lipid based DDS were mainly composed of medium-chain triglycerides and a mixture of surfactants, while the multicomponent inclusion complex systems involved cosolvents and different cyclodextrins. The method was validated according to the International Conference on Harmonization guidelines. The linearity of the standard curves was greater than 0.999 (r²) with the limits of detection of 0.05 µg/mL and quantification of 0.18 µg/mL. The method was specific, precise (RSD < 1.99%) and robust. The different drug interactions with systems did not alter the recovery which ranged from 93 to 106% for the distinct DDS. Statistical data analysis of different DDS demonstrated that selected parameters for HPLC−DAD method offered equivalent results and could be applied for stability studies and quality control of these drug delivery systems.

中文翻译：

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高效液相色谱-二极管阵列检测器方法用于脂质和自组装环糊精药物递送系统中苯并咪唑的定量

摘要

当前工作的挑战在于使用HPLC-二极管阵列检测器（DAD）方法在两个药物递送系统（DDS）中的溶解度特征和样品复杂性不同的苯并硝唑测定。基于脂质的DDS主要由中链甘油三酸酯和表面活性剂混合物组成，而多组分包合复合物系统则涉及助溶剂和不同的环糊精。该方法已根据国际协调会议指南进行了验证。标准曲线的线性度大于0.999（r ²）的检出限为0.05 µg / mL，定量限为0.18 µg / mL。该方法特异，精确（RSD <1.99％）且稳定。不同药物与系统的相互作用不会改变回收率，对于不同的DDS，回收率介于93％至106％之间。对不同DDS的统计数据分析表明，用于HPLC-DAD方法的选定参数可提供相同的结果，并可用于这些药物递送系统的稳定性研究和质量控制。