Analytical Method Development and Validation of RP-HPLC method for the Estimation of Abemaciclib Content in Tablet Dosage Form

A simple, precise, accurate and reproducible RP-HPLC technique has been developed and validated for the quantitative measurement of Abemaciclib in Tablet dosage form. The drug was analyzed isocratically and separated using an Inertsil ODS C18 column (250mm X 4.6mm, 5 µm). The mobile phase consisted of 25 mM di-potassium hydrogen orthophosphate and 0.1% triethylamine in water pH adjusted to 2.5 with orthophosphoric acid: Acetonitrile in a 60:40% v/v ratio, and the temperature of the column was kept at 40oC and a flow rate of 0.7 ml/min was used. With the same mobile phase as the diluent, 10 µl of the solution was injected into the system and the peak area was measured at 298 nm. The developed RP-HPLC technique was validated in accordance with the ICH Q2 (R1) guidelines. The retention period of Abemaciclib was to be approximately 5.60 minutes. The drug demonstrated linearity within the concentration range of 5-100 µg/ml, with a correlation coefficient of 0.9999. The mean percent recovery of Abemaciclib was determined to be 99.96%. The limit of detection (LOD) and limit of quantification (LOQ) of Abemaciclib were determined to be 1.14µg/ml and 3.47µg/ml. The validation exercise revealed that the developed HPLC technique was accurate, specific, precise, rapid, reliable, and reproducible; hence, it can be used for quality control analysis of Abemaciclib in unitdosage form.