Stability Indicating Reverse Phase High-Performance Liquid Chromatography Method for Quantitative Estimation of Impurities in Gadobutrol Solution for Intravenous Administration

Abstract

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.