稳定性指示反相高效液相色谱法定量测定静脉给药加多布特罗溶液中杂质

Sanni Babu Najana
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引用次数: 0

摘要

以Phenomenex Phenyl-Hexyl C18为色谱柱,以甲酸(pH 3.6)和乙腈为流动相,采用等密度洗脱,建立了Gadobutrol和杂质a、B、C的HPLC分析方法。所建立的方法对Gadobutrol在0.8314 ~ 30.21 ppm、3.2971 ~ 34.62 ppm(杂质- a)、0.3788 ~ 34.82 ppm(杂质- b)和2.9757 ~ 32.38 ppm范围内具有良好的线性关系。方法精密度(RSD = 2.36% ~ 3.55%)、准确度(98.8% ~ 108.9%)、检出限(0.1250 ppm ~ 1.0811 ppm)和定量限(0.3788 ppm ~ 3.2971 ppm)均可用于评价Gadobutrol样品中杂质A、B、C的存在。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability Indicating Reverse Phase High-Performance Liquid Chromatography Method for Quantitative Estimation of Impurities in Gadobutrol Solution for Intravenous Administration
The purpose of this investigation was to establish a HPLC methodology and evaluate Gadobutrol along with impurities A, B and C. The method for Gadobutrol along with impurity-A, B and C analysis was developed on Phenomenex Phenyl-Hexyl C18 column with isocratic elution using mobile phase consisted of formic acid (pH 3.6) and acetonitrile. The method proposed showed a good linearity in the range of 0.8314 – 30.21 ppm (Gadobutrol), 3.2971 – 34.62 ppm (impurity-A), 0.3788 – 34.82 ppm (impurity-B), and 2.9757 – 32.38 ppm for impurity-C. Obtained good method precision (RSD = 2.36% to 3.55%), acceptable accuracy (98.8% to 108.9%), detection limit (0.1250 ppm to 1.0811 ppm) and quantitation limit (0.3788 ppm to 3.2971 ppm) for Gadobutrol and impurity-A, B and C. The method proposed can be utilized to assess the quality of Gadobutrol sample for the presence of impurities A, B and C.
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来源期刊
Bioscience Biotechnology Research Communications
Bioscience Biotechnology Research Communications BIOTECHNOLOGY & APPLIED MICROBIOLOGY-
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