Simultaneous Determination of Five Genotoxic Aryl Sulfonate Impurities in Pharmaceuticals by LCMS-2050

User Benefits

- A novel method for determining the content of five genotoxic aromatic sulfonate impurities in drugs was established by using LCMS-2050 single quadrupole mass spectrometer. - The pretreatment of this method was simple, and it had a wide linear range and a high accuracy rate.

Introduction

Genotoxic impurities (GTIs) refer to substances that directly or indirectly damage cellular DNA, generating gene mutations or in vivo mutagenesis. GITs may can cause damage to human genetic material at extremely low concentrations, which in turn leads to gene mutations and promotes the occurrence of tumors. Because of the potential risks of GITs, it is essential to monitor any potentially existing genotoxic impurities in active pharmaceutical ingredients or medicinal products. In the pharmaceutical industry, when drug active ingredients exist in the forms of alkyl sulfonates, benzenesulfonates, ptoluenesulfonates, and hydroxyethyl sulfonates or sulfonic acid reagents are utilized in the drug synthesis process, sulfonate esters are regarded as potential GTIs. GTIs of sulfonate esters can be classified as alkyl sulfonate esters and aryl sulfonate esters based on different substituents. Previously, relevant literature has reported quantitative detection methods for some GTIs of sulfonate esters, such as GC-MS, GC-FID, LC-MS/MS, and complex derivatization treatment of samples might be necessary. In this study, LC-MS was mainly utilized for the quantitative analysis of five GTIs of aryl sulfonate esters. This method features simple pretreatment and high accuracy, which can offer a reference for the detection of genotoxic impurities of aryl sulfonate esters in drugs.

January 22, 2025 GMT