Efficient Method Development on Pharmaceutical Impurities Using Single Quadrupole Mass Spectrometer

User Benefits

- Peak tracking using an LCMS-2050 single quadrupole mass spectrometer supports highly reliable method development by accurately tracking each impurity that has similar UV spectra. - LabSolutions MD is efficiently able to develop method that provides both excellent resolution and shorter analysis time.

Introduction

Since pharmaceutical impurities require strict control to ensure safety, development of highly reliable analytical method is essential. LabSolutions MD, a new Shimadzu software for method development, supports efficient method development based on Analytical Quality by Design (AQbD). AQbD-based analytical method development consists of the phases of initial screening, optimization, and robustness evaluation. This article introduces an example of its use for the development of a robust LC method for impurities on Montelukast (a medication used in the maintenance treatment of asthma). By changing each parameter of gradient program, the resolution of Montelukast and each impurity was evaluated by visualizing through “design space.” Though it was previously difficult to accurately track each impurity with similar UV spectra using photodiode array detector (PDA), LCMS-2050 can solve this problem. Furthermore, by utilizing design space of resolution and RT of last eluting peak, it is possible to efficiently develop method that provides both excellent resolution and shorter analysis time.

November 24, 2022 GMT