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

Abstract

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.

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“…TQ's peak area, Rt, N and Tf were calculated to identify the optimal approach. The technique for analysis was developed by experimenting with various mobile phase ratios, flow rates and column oven temperature 2,3 .…”

“…For photo deterioration, drug samples were subjected to UV light. In all of the preceding investigations, materials were diluted with an adequate amount of mobile phase before being exposed to HPLC analysis [3][4][5] .…”