简单经济的紫外分光光度法测定氢溴化乙曲坦的曲线下面积

Mahesh Deshpande, V. Kasture, M. Mohan
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引用次数: 0

摘要

目的:建立一种简便、经济的曲线下面积法测定氢溴酸乙曲坦的含量。方法:氢溴化伊曲坦的测定溶剂为水。λmax为221 nm。紫外光谱曲线下面积在216 ~ 226 nm之间。该方法按照ICH指南Q2(R1)进行验证。结果:伊曲霉坦HBr在5 ~ 25 μg/ml范围内呈线性关系。相关系数为0.999。日内、日间精密度%RSD均在可接受范围内。定量限和定量限分别为5.77 μg/ml和1.90 μg/ml。Eletriptan HBr的回收率为99.66 ~ 99.95。粗犷值表示该方法是坚固的。结论:所建立的方法可用于依曲坦HBr的常规分析,并符合ICH Q2 (R1)的处方要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Simple and Economical UV Spectrophotometric Area under Curve Method for Estimation of Eletriptan Hydro bromide
Objective: Simple and economical area under curve method was developed and validated for the estimation of Eletriptan Hydrobromide. Method: The solvent implemented for estimation of Eletriptan Hydrobromide was water. The λmax was found to be 221 nm.The area under curve of UV spectrum between 216 to 226 nm. The method is validated according to ICH guideline Q2(R1). Results: The linearity range of Eletriptan HBr was found to be 5-25 μg/ml. The correlation coefficient was found to be 0.999. The values of %RSD for inter and intra-day precisions were within the acceptable limit. LOD and LOQ were found to be 5.77 μg/ml and 1.90 μg/ml respectively. % Recovery of Eletriptan HBr was 99.66 to 99.95.The values of ruggedness shows the method is rugged. Conclusion: The developed method can be implemented for routine analysis of Eletriptan HBr in bulk as well as formulation as per ICH Q2 (R1) guidelines.
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