Daiichi Sankyo Co., Ltd. Pharmaceutical Technology Division Analytical Evaluation Laboratory Research First Group Researcher Tsukasa Sasaki
Reversed-phase HPLC is an important analytical scientific method for estimating the effectiveness and safety of small molecule drugs.In general, the main component of a pharmaceutical is a mixture containing a certain amount of impurities, but the amount of each component can be estimated by using reverse phase HPLC.Therefore, the search and optimization of HPLC conditions for reproducible separation of each component is a very important process in quality assessment research.The main factors that affect the separation include the pH of the buffer used in the eluent, the organic solvent species, the analytical column temperature, the flow rate of the eluent, etc. Especially when the target is an ionic compound, the pH and the organic solvent species Greatly affects the success or failure of separation.However, in reverse-phase HPLC, the variation in the time (retention time) each component passes through the analytical column is not linear with respect to factors such as pH and organic solvent, and it is very important to evaluate the success or failure of the separation by predictive reasoning Have difficulty.Therefore, the performer tried an approach to estimate the success or failure of separation in a certain eluent condition range from the retention time prediction by neural network modeling.
