A validated stability indicating rp-hplc method development and validation for estimation of trilaciclib in bulk and pharmaceutical dosage form

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V.Shireesha, A.Priyanka Netha, Dr. S.Srinivasa Rao, Dr. Subhas Sahoo

This study proposes a rigorous and precise (RP-HPLC) method for the measurable analysis of Trilaciclib in pharmaceutical dosage forms. The Portable stage employed in this study was an Ascentis column measuring 15cm in length and 4.6mm in diameter, with a particle size of 5μm. A solvent stage consisting of a 0.01N Na2HPO4 solution in a mixture of methanol and water (in a ratio of 55:45) was continuously delivered at a flow rate of 0.9 mL/min, while maintaining a temperature of 30°C. A frequency of 220.0 nm was recorded. The half-life of Trilaciclib was determined to be 2.182 minutes. The percent relative standard deviation (PercentRSD) for system precision was determined to be 1.3%, whereas the percent relative standard deviation (PercentRSD) for process precision was found to be 0.4%. The recovery

rate achieved was 99.56%. The LOD and LOQ values obtained from the R2 analysis were determined to be 0.38 and 1.16, respectively. The coefficient of determination (R2) for the linear regression model, where the dependent variable (y) is predicted by the independent variable (x), is equal to 0. The implementation of this method led to a into an enterprise quality control examination.

Method development, Validation, RP-HPLC