Estimation and Validation of Abrocitinib Dosage Form and in Bulk Drug by Spectrophotometric Method

Husnain Fathima, Mohammed Yakhoob, Mohamed Khaleel
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Abstract

A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Abrocitinib in pure drug and tablet dosage form. The absorbance was measured at 303.0nm using Dimethylsulfoxideas solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml with coefficient of correlation (r2) of 0.998. Limit of detection (LOD) was found to be 1.226µg/ml and Limit of quantitation (LOQ) was found to be 5.226µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.
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分光光度法对阿布替尼剂型和原料药的评价与验证
建立了一种简便、灵敏、准确、快速、经济的分光光度法测定和验证阿布昔替尼纯药和片剂剂型的方法。用二甲基亚砜溶液在303.0nm处测定吸光度。在2 ~ 14µg/ml浓度范围内符合比尔定律,相关系数(r2)为0.998。检测限(LOD)为1.226µg/ml,定量限(LOQ)为5.226µg/ml。所提出的分析方法根据ICH指南进行了验证,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。
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