Analysis of Potential Genotoxic Arylamine and Aminopyridine Impurities in Active Pharmaceutical Ingredients Agilent 1290 Infinity LC system and Agilent 6460A Triple Quadrupole MS system for method development and fast analysis
نویسندگان
چکیده
This Application Note illustrates the possibilities of the Agilent 1290 Infinity LC system and the Agilent 6460A Triple Quadrupole Mass Spectrometer for quantitative analysis of potential genotoxic impurities (PGIs) in active pharmaceutical ingredients (APIs). A generic approach was used to determine arylamine and aminopyridine PGIs in selected APIs. The influence of column length and mobile phase composition on the recovery of these impurities in real samples were investigated. High resolution UHPLC using a 150 mm RRHD column packed with 1.8 μm particles resulted in the best overall performance. In cases of good separation between API and the target solutes, analysis speed and sample throughput could be increased using a 50 mm RRHD column. Detection limits were below 20 ppb (ng/g, relative to the API) using MS/MS and below 100 ppb (ng/g, relative to the API) with DAD for 2,6-dichloroaniline, which could not be detected with ESI-MS at trace levels. Authors Gerd Vanhoenacker, Frank David, Pat Sandra Research Institute for Chromatography Kortrijk, Belgium Application Note Pharmaceutical
منابع مشابه
Analysis of Four β-Lactam Antibiotics in Water Using an Agilent 1290 Infinity II LC and an Agilent 6470 Triple Quadrupole LC/MS with Direct Injection and Online SPE
متن کامل
Enhancing the Productivity of Pharmaceutical Workfl ows Using the Agilent 6150 Single Quadrupole Mass Spectrometer
Simple, generic methods are commonly used for the routine screening of new molecular entities in a drug discovery environment. Here we describe a versatile LC/MS method that was developed using an Agilent 6150 Single Quadrupole (SQ) Mass Spectrometer coupled to an Agilent 1290 Infi nity LC System that is suitable for molecular weight confi rmation or impurity analysis. The UHPLC system is capab...
متن کاملFast analysis of ink dyes using the Agilent 1290 Infinity LC System coupled to Agilent 6140 single quadrupole LC/MS System for forensic analysis of ink pens and markers
In forensics, the analysis of ink writings from documentation is required for authentication or crime analysis. Ten organic ink dye components typically found in ink pens were separated using the Agilent 1290 Infinity LC System and quantified using the Agilent 6140 single quadrupole LC/MS System. The dyes were separated in less than 3.5 min using a sub-2-μm, 30 mm column. Analysis of ink markin...
متن کاملFast screening of mobile and stationary phases with the Agilent 1290 Infinity LC and seamless method transfer to an Agilent 1200 Series LC using ISET
This Application Note describes how the Agilent 1290 Infinity LC System Method Development Solution was used to find optimum separation conditions for degradation products of a pharmaceutical preparation. Having evaluated the optimum combination, a transfer to conventional conditions was performed. Finally, the Agilent Intelligent System Emulation Technology (ISET) of the 1290 Infinity LC was u...
متن کاملAdapting EPA Method 8330B for Analysis of Explosives in Water to SPE and LC/MS/MS Authors
EPA Method 8330B for trace explosives in water by HPLC was transferred from UV detection to mass spectrometry detection using the Agilent 1290 Infinity LC System coupled to the Agilent 6460 Triple Quadrupole LC/MS System using APCI negative mode. Eleven explosive compounds were analyzed with this method at trace concentrations in water samples with limits of detection at the 5–50 ng/L concentra...
متن کامل