紫外分光光度法和比色法测定伊鲁替尼剂型和原料药的含量

Sheema Sultana, Nirmal. T. Havannavar, Husnain Fathima
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引用次数: 1

摘要

建立了一种简便、灵敏、准确、快速、经济的分光光度法和比色法测定伊鲁替尼纯药和片剂剂型的方法。以乙醇为溶剂体系,在248nm和552nm处测定吸光度。在2 ~ 14µg/ml和1 ~ 5µg/ml浓度范围内符合比尔定律,相关系数(r2)分别为0.998和0.996。检测限(LOD)分别为1.226µg/ml和1.000µg/ml,定量限(LOQ)分别为5.226µg/ml和2.760µg/ml。根据ICH指南验证了所提出的分析方法,在范围、线性、精密度、准确度、稳健性和耐用性方面取得了良好的结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Estimation of Ibrutinib in Dosage Form and in Bulk Drug by UV Spectrophotometric and Colorimetry Methods
A simple, sensitive, accurate, rapid and economical Spectrophotometric and colorimetric methods was developed for estimation of Ibrutinib in pure drug and tablet dosage form. The absorbance was measured at 248nm and 552nm using ethanol as solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml and 1-5µg/ml with coefficient of correlation (r2) of 0.998 and 0.996. Limit of detection (LOD) was found to be 1.226µg/ml and1.000µg/ml Limit of quantitation (LOQ) was found to be 5.226µg/ml and 2.760µg/ml. The proposed analytical methods were validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.
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