HPLC method development support software follows the principle of “quality by design”


COLUMBIA, MD – Shimadzu, a world leader in analytical instrumentation, introduces LabSolutions MD software for analytical method development for high performance liquid chromatography (HPLC). In addition to featuring established methods search functionality that allows for automated, fast and simple column and solvent screening.

LabSolutions MD provides rapid identification of optimal separation conditions using a Design of Experiments (DoE).

When using the traditional trial and error approach, a great deal of experimentation may be required to establish an appropriate separation method, especially with complex samples. LabSolutions MD, using multifactorial design, requires only a limited amount of experimental data to create a defined design space. Computer simulation and modeling of retention in this design space enables rapid, statistically informed decisions on appropriate separation conditions, while reducing the risk of human error.

Additionally, LabSolutions MD supports Analytical Quality by Design (AQbD), as proposed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), to emphasize the scientific basis and risk assessment for newly developed analytical methods.

In combination with Shimadzu’s Nexera UHPLC method explorer system, LabSolutions MD software offers a graphical user interface to simplify system setup, as well as automated batch creation to deliver reliable data that minimizes the risk of human error. It allows screening of various combinations of different mobile phases and separation columns to quickly identify an appropriate combination visually and quantitatively based on specified parameters, such as number of peaks separated and resolution.

With the combination selected, LabSolutions MD can then create a multi-factor experimental design, while using only limited input data, to determine the optimal separation conditions in the design space. Accurate retention modeling allows an estimation of the robustness of the method in a minimum of time.

LabSolutions MD users can also visualize the effect of changes in analytical conditions on chromatographic resolution in the design space in a color-coded map that allows effortless identification of robust method conditions, where separation is less likely. to be affected by small variations in method parameters. Computer simulation can be used to create a virtual chromatogram analysis view with specified conditions.

LabSolutions MD, in combination with the Shimadzu LabSolutions Chromatography Data System (CDS), provides data management, statistical evaluation, and intuitive reporting, all within a LabSolutions database, ensuring data integrity .

LabSolutions CDS creates summary reports that include all the data collected. Additionally, the software can provide integrated management of the entire sequence of files in a database to ensure data integrity.


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