Development and validation of a RP-HPLC method for Milrinone quantification using analytical quality by design principles: stability, precision, and method optimization

A research study demonstrates successful implementation of Analytical Quality by Design for creating a solid and dependable Reverse Phase High-Performance Liquid Chromatography technique to determine Milrinone concentrations. The study presents evidence for using AQbD principles during method development practices. Response surface methodology underwent optimization with chromatographic conditions to establish proper separation resulting in a 1.901 minutes retention time. The implementation of Reverse Phase High-Performance Liquid Chromatography demonstrates how AQbD provides method precision as well as accuracy and reliability during Milrinone quantification. The system suitability test produced smooth peaks with high efficiency that generated USP tailing factor 1.0 and plate count 10,795. The precision tests showed that the method possessed 0.3% for %RSD thus indicating strong method reliability and precision. The developed method achieved outstanding results through all test conditions which demonstrated linearity with R2 = 0.999 alongside accuracy through recovery rates of 99.9–101.1% while performing robustly in minor variation tests. The validated tests showed excellent reliability because they proved high accuracy alongside precision and linearity. The stability experiments demonstrated different stress conditions but the main challenge was photolytic degradation.