Analysis of Impurities in Montelukast Using Single Quadrupole Mass Spectrometer

User Benefits

- Easy to obtain molecular weight information of APIs about main components and impurities contained in pharmaceuticals. - Compound structures can be deduced by acquiring a pseudo-MS/MS spectrum through in-source CID .

Introduction

Official documents such as the Japanese Pharmacopoeia (JP), the European Pharmacopoeia (EP), and the United States Pharmacopeia (USP) describe the structural formulae of impurities in pharmaceuticals, and the identification of trace impurities in pharmaceuticals is important for quality assurance. The HPLC-UV method is widely used to evaluate the purity, and if any impurity is detected, it must be identified. In such analyses, the standard approach is then to connect a mass spectrometer (LC-MS) and obtain molecular weight information to help with identification. This report presents an example of the analysis of impurities in montelukast sodium using the Nexera^TM series high- performance liquid chromatograph and the LCMS-2050 high- performance liquid chromatography-mass spectrometer. Montelukast sodium is listed in the 17th edition of the Japanese Pharmacopoeia and is used to treat bronchial asthma and allergic rhinitis. This article shows 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