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用于测定原料药及药物制剂中盐酸度洛西汀的荧光分光光度法。

Spectrofluorimetric method for determination of duloxetine hydrochloride in bulk and pharmaceutical dosage forms.

作者信息

Prabu S L, Shahnawaz S, Kumar C Dinesh, Shirwaikar A

机构信息

Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal-576 104, India.

出版信息

Indian J Pharm Sci. 2008 Jul-Aug;70(4):502-3. doi: 10.4103/0250-474X.44603.

Abstract

A simple accurate, sensitive and reproducible spectrofluorimetric method was developed for the analysis of duloxetine hydrochloride in pure and pharmaceutical dosage form. Duloxetine hydrochloride showed strong native fluorescence in 0.05 M acetic acid having excitation at 225 nm and emission at 340 nm. Effect of different solvents were thoroughly investigated. The calibration graph was linear in the range from 0.020 to 0.400 mug/ml. The proposed method was statistically validated and successfully applied for analysis of capsule dosage forms. The limit of detection and limit of quantification were found to be 0.003 mug/ml and 0.010 mug/ml, respectively. The percentage recovery was found to be in the range of 98.71% to 99.17%.

摘要

开发了一种简单、准确、灵敏且可重现的荧光分光光度法,用于分析纯品和药物剂型中的盐酸度洛西汀。盐酸度洛西汀在0.05 M乙酸中表现出强烈的固有荧光,激发波长为225 nm,发射波长为340 nm。深入研究了不同溶剂的影响。校准曲线在0.020至0.400 μg/ml范围内呈线性。该方法经过统计学验证,并成功应用于胶囊剂型的分析。检测限和定量限分别为0.003 μg/ml和0.010 μg/ml。回收率在98.71%至99.17%范围内。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7573/2792555/894f2f3d9fff/IJPhS-70-502-g001.jpg

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