This study implies to development of a sensitive liquid chromatography tandem mass spectrometry method. Further using this method ribociclib can be estimated in the drug formulation. Ribociclib was recently approved by the United States Food and Drug Administration in the year 2017 for metastatic and advanced breast cancer, which is used for resistant patients to endocrine therapy and it targets cyclin-dependent kinase 4 and 6 inhibitors. The stationary phase was Phenomenex C18 (50 × 4.6 mm, 3 microns), with a mobile phase combination of acetonitrile and 10 mM ammonium acetate (90:10 v/v ratio) with a flow of 0.7 ml/minutes. Ribociclib was detected using liquid chromatography-tandem mass spectrometry in positive transition at m/z 435.0. The linearity ranges between 5 and 100 ng/ml. The Ribociclib correlation coefficient (R2) was linear, with an R2 value of 0.9991. The drug had a retention time (RT) of 1.022 minutes, and a total run time of 3 minutes. According to the literature survey, there is a limited isocratic method for the selected drug hence, we developed an isocratic which is a quick, accurate, and efficient method for determining ribociclib and its formulation.
Key words: Ribociclib, Cyclin-Dependent Kinase blocker, Liquid Chromatography Tandem Mass Spectrometry, Method Validation, Formulation.
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