Analytical Quality by Design develops a reliable RP-HPLC method for measuring Landiolol, indicating its usefulness in pharmaceuticals.
Key Points
The objective is to develop and validate a reverse-phase high-performance liquid chromatography method for quantifying Landiolol in pharmaceutical formulations.
Utilized Central Composite Design for method optimization.
Validated chromatographic conditions with specific column and mobile phase compositions.
Assessed system suitability and precision through standard metrics.
Performed accuracy studies and forced degradation assessments.
Achieved an F-value of 11.60 and a p-value of 0.0003, indicating significant model validity.
Demonstrated excellent system suitability with USP tailing factor of 1.0 and plate count of 10,925.
Showed exceptional reproducibility with a %RSD of 0.3%.
Achieved a linearity R² of 0.9999, and recoveries ranged from 100.8 to 101.1%.