Optimization of Ion Analytical Conditions in Pharmaceuticals Using LabSolutions MD

User Benefits

- Using software, each parameter can be varied comprehensively and easily, enabling efficient analysis method development. - Resolution and analysis parameter relationships can be visually assessed and the valid parameter areas can be confirmed.

Introduction

The physicochemical and pharmacokinetic properties of active pharmaceutical ingredients change depending on the counterion. In the drug development stage, various counterions are tested and selected as appropriate salts. Residual inorganic impurities such as catalysts and ions used the synthesis stage can affect product safety, solubility, and stability, so it is very important to analyze ions as impurities. In this article, an analysis example using ion exclusion chromatography is described. Formic acid, acetic acid, fumaric acid, and maleic acid, which are organic acids frequently used for drug counterions, were analyzed in the example. Response was visualized by drawing design spaces while comprehensively changing each parameter, and analytical conditions were optimized by using LabSolutions^TM MD and LC- 2050C 3D.

October 26, 2022 GMT