Stability Indicating UPLC Method for Quantitative Estimation of Gadobutrol in Gadobutrol Solution for Intravenous Administration
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Abstract
A simple and rapid stability-indicating, reversed phase ultra-performance liquid chromatography (UPLC) method was developed for the quantitative estimation of Gadobutrol in Gadobutrol solution for intravenous administration. The separation was achieved on Acquity UPLC CSH Phenyl-Hexyl (150 x 2.1mm, 1.7µm), in mobile phase consisted of pH 3.8 ammonium acetate buffer and acetonitrile in the ratio of (85:15 volume/volume). The flow rate was maintained at 0.5 mL/ min. UV detection was carried out at 195 nm. Column oven temperature was maintained 40°C and sample cooler temperature 5°C, injection volume 2 µL and run time was 6 minutes. The retention time of Gadobutrol was noted to be 3.1 minutes respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.