Optimization of a Liquid Chromatography Method for the Analysis of Related Substances using Design of Experiments Integrated with the Steepest Ascent Method and Monte Carlo SimulationFriday, 12 October 2018 at 12:30 Add to Calendar ▼2018-10-12 12:30:002018-10-12 13:30:00Europe/LondonOptimization of a Liquid Chromatography Method for the Analysis of Related Substances using Design of Experiments Integrated with the Steepest Ascent Method and Monte Carlo SimulationPharmaAQ in MumbaiMumbaiSELECTBIOenquiries@selectbiosciences.com An analytical method for the determination of related substances (RS) was optimised using quality by design (QbD) approach. The DoE study uncovered hidden peaks and unknown criticalities, which would eventually lead to method and product failure. Since this was a sensitive case of method development it was treated accordingly, and techniques such as method of steepest ascent were adopted to attain the optimum condition. Finally, the method robustness was proved and fortified through capability analysis and Monte Carlo simulations and this is going to be a focus of Ms Tol’s talk. |