High performance liquid chromatographic analysis method for related substances of regadenoson
2016
The invention discloses a high performance liquid chromatographic analysis method for related substances of regadenoson. According to the method, a reversed phase column and an ultraviolet detector are adopted, and a 1-alkyl sodium sulfonate solution-methanol is adopted as a flowing phase for gradient elution. By the method, all known impurities in regadenoson raw materials and a preparation can be analyzed at the same time, the content of each known impurity can be effectively controlled by a principal component self-contrast method adopting a correction factor, degrees of separation between each impurity peak as well as between a major peak and an adjacent impurity peak are all more than 1.5, and the peak impurity of the major peak and each impurity peak is higher than 1.0. A simple and reliable analysis method is provided for quality control over the regadenoson raw materials and the preparation.
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