Shimadzu’s New Nexera FV Ultra High Performance Liquid Chromatograph Dramatically Reduces the Time Spent Conducting Dissolution Tests for the Development and Quality Control of Pharmaceuticals

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Evaluation of the dissolution of drug products is important in the development and quality control of pharmaceuticals. Especially for generic pharmaceuticals, a dissolution test must be performed to validate their bioequivalence and whether it has been changed by the content and dosage form. Ultraviolet spectrophotometers are mainly used to measure the dissolution amount. However, a high-performance liquid chromatograph (LC) is used when the component concentration in drug products is low, components are easily hydrolyzed, or combination drugs (tablets containing multiple components) are being examined.

An issue with dissolution tests using LC is complicated operation. When using a system in which the eluate is not automatically delivered from the dissolution tester to the LC unit, the operator needs to stay with the tester for a long time because they need to transfer the eluate (sampling). In contrast, the Nexera FV does not require manual sampling because the eluate can be automatically delivered to the LC unit for direct analysis. Using the Nexera ultra high performance analysis LC system as the LC unit enables ultrafast analysis of the eluate.