AQbD for an HPLC Method: A Practical Step-by-Step Example | Spectratix Pharma

New to Analytical Quality by Design (AQbD)? This video takes you through all 8 steps of AQbD using one example from start to finish: a stability-indicating HPLC method for Drug X and its two impurities, A and B. You’ll see how a weak first method, where Impurities A and B co-elute with a resolution of 1.1, becomes a robust method with a resolution of 3.1. We follow ICH Q14 and USP 1220. It’s made for freshers and early-career analysts in QC, AR&D and method development. By the end, you should be able to apply AQbD to your own method. What you’ll learn: ✅ How to write an Analytical Target Profile (ATP) ✅ How to choose critical method attributes, and find the critical pair ✅ How forced degradation shows that a method is stability-indicating ✅ Risk assessment with a 6M fishbone diagram and FMEA ✅ Screening and optimization DoE ✅ How to build the method operable design region (MODR) and pick a working point ✅ Control strategy, ICH Q2(R2) validation and lifecycle management The data in this video is for illustration only. Use your own product’s data and your company’s SOPs when you develop a method. Spectratix Pharma Pvt. Ltd.: Fostering Innovation, Building Expertise 👍 If this helped, like the video, subscribe for more analytical training, and share it with your team. #QbD #pharmacy #hplc #analytical #ICH #pharmatraining #chemistry #stability