Shimadzu and Molnár Institute
Shimadzu, one of the worldwide leading manufacturers in analytical instrumentation, cooperates with the Berlin/Germany based Molnár- Institute in applying the new DryLab 2010 software and the new generation of Shimadzu UHPLC instruments. QbD automated HPLC Method Development using DryLab 2010 enables the transfer of HPLC methods into most-modern Shimadzu UHPLC technology. By remaining in the design space, much higher flexibility is achieved in adjusting working conditions according to individual needs.
DryLab 2010 and Shimadzu’s LabSolutions software complement each other perfectly. LabSolutions provides a platform for all of Shimadzu’s chromatographic systems. Even 3D detection technologies are covered. DryLab 2010 targets method development and applications to run under regulated environment with a special focus on the pharmaceutical industry. The software’s reliability rate is 99.8%. More than 106 experiments can be modelled based on a set of 12 basic experiments under pre-defined conditions.
DryLab 2010 now enables simultaneous optimisation of several measured experimental parameters (tG, T, pH, ternary composition of eluent B, buffer or additive concentration) with nine other derived factors (column length, -ID, particle size, flowrate, %B(start), %B(end), gradient steps, dwell volume, extra column volume) to further define the Design Space of a separation. The 3D Cube is calculated based on 12 experiments using three gradient time-temperature (tG-T) models with one additional factor and it represents over one million modelled chromatograms and evaluates multiple parameters simultaneously.
DryLab is useful in almost all chromatography applications in the lab. The software helps to develop complete methods in minimal time, shorten run times, find the best separation conditions for any component in a mixture and transfer methods to better and more modern instruments such as Shimadzu’s Nexera.
FDA, ICH and other regulatory authorities promote and request application of QbD principles to simplify the exchange of complex information on chromatographic selectivity and critical resolution values, so as to support better method control including method transfer. Furthermore, the ICH Q8 has made a clear movement towards more flexibility in supporting development of new products.
DryLab has applied the QbD principle for 20 years with a systematic evaluation of parameters influencing method performance such as selectivity and resolution. DryLab simplifies and speeds up the process of developing excellent chromatographic separations by enabling users to model changes in separation conditions using their personal computer. The time-consuming laboratory runs which are typically required to achieve a satisfactory separation or development of a complete method are replaced with instantly generated chromatograms corresponding to conditions that can be individually selected.
DryLab® 2010 is registered trademark of Molnár-Institute