Stability Demonstrating Validated High Pressure Liquid Chromatographic Method for the Determination of Trilaciclib in Bulk and Pharmaceutical Formulation

Aims: New validated method for the estimation of Trilaciclib using HPLC and study of its degradation

Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between February 2021 and August 2021.

Methodology: Using an inertsil ODS column (150 mm x 4.6 mm, 3.5 µ), acetonitrile, and 0.1 percent ortho phosphoric acid (OPA) (50:50 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 220 nm. Trilaciclib had a retention time of 4.358 minutes. The isocratic chromatography was performed at room temperature and took approximately six minutes to complete.

Results: Analysis was achieved within 6 min over an honest linearity within the concentration range from 3-45 µg/ml of Trilaciclib. Using a mathematical process, the suitability parameters of the system were investigated, and the results were found to be in acceptable limits. In a linear analysis, stages with regression coefficients of 0.999 were used. LOD and LOQ values were 0.038 μg/ml and 0.124 g/ml for trilaciclib. The drug was recovered at a rate of 98-102 percent, which means that the recovery is within reasonable limits.

Conclusion: The validation results were satisfactory, and the approach was found to be suitable for bulk and formulation analysis. The recommended procedure was found to be warranted according to ICH guidelines.