Analysis of Impurities in Atorvastatin Using Single Quadrupole Mass Spectrometer

User Benefits

- Easy to obtain molecular weight information of APIs and impurities contained in pharmaceuticals. - Detected masses of APIs and impurities can be viewed directly on UV chromatograms for easy interpretation. - Compound structures can be deduced by acquiring a pseudo-MS/MS spectrum through in-source CID.

Introduction

In addition to the API, drug substances contain trace amounts of impurities such as side reaction products, unreacted residues, and degradation products. When impurities are contained above the threshold specified in ICH-Q3, it is necessary to confirm their structure and safety. The HPLC-UV method is generally used to evaluate the purity, and if an impurity is detected, it is required to confirm its identity. In this analysis, it is a standard approach to further connect a mass detector (LC-MS) to obtain molecular weight information that helps with impurity identification. Using the LC-MS system, it is possible to further deduce the molecular structure by performing MS/MS analysis. In this report, we present an example of an analysis of a pharmaceutical product containing impurities using the LCMS- 2050 high-performance liquid chromatography-mass spectrometer. We will show how mass information can be automatically added to absorbance detector data for easy peak identification, and furthermore, how impurities can be analyzed and identified using in-source CID.

May 31, 2022 GMT