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荧光光谱法测定伊伐布雷定原料药及其片剂的含量。

Fluorescence spectroscopy method for estimation of Ivabradine in bulk and the tablet dosage form.

机构信息

Maliba Pharmacy College, Uka Tarsadia University, Gopal Vidyanagar, Bardoli Mahuva Road, Tarsadi, Dist, Surat, Gujarat, India.

Maliba Pharmacy College, Uka Tarsadia University, Gopal Vidyanagar, Bardoli Mahuva Road, Tarsadi, Dist, Surat, Gujarat, India.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2022 Jan 5;264:120330. doi: 10.1016/j.saa.2021.120330. Epub 2021 Aug 27.

DOI:10.1016/j.saa.2021.120330
PMID:34481253
Abstract

A simple and sensitive spectrofluorimetric method has been developed for the estimation of Ivabradine HCl in bulk and the tablet dosage form. Ivabradine HCl in methanol produces fluorescence at 325 nm (λem) with excitation at 287 nm (λex). The linearity range was found to be 100-500 ng/ml with a correlation coefficient of 0.999. The limit of detection (LOD) and limit of quantitation (LOQ) for the developed method were found to be 8.38 and 25.39 ng/ml, respectively. The developed method was found to be specific, sensitive, accurate, and precise. It was successfully used for the estimation of Ivabradine HCl in its tablet dosage form. The content of Ivabradine HCl in marketed formulations was found to be 101.25 ± 1.16 % of label claims.

摘要

已开发出一种简单灵敏的荧光分光光度法,用于盐酸伊伐布雷定的含量测定。在甲醇中,盐酸伊伐布雷定在 287nm(λex)激发下于 325nm(λem)处产生荧光。线性范围为 100-500ng/ml,相关系数为 0.999。该方法的检测限(LOD)和定量限(LOQ)分别为 8.38 和 25.39ng/ml。该方法具有专属性、灵敏性、准确性和精密度。已成功用于其片剂制剂中盐酸伊伐布雷定的含量测定。市售制剂中盐酸伊伐布雷定的含量为标签声称的 101.25±1.16%。

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