Gas Chromatography-Head Space-Flame Ionization Sensor based assessment of four residuary solvents in rivaroxaban bulk medication

Abstract

In this research we established a new GC-HS-FID (Gas Chromatography-Head Space-Flame Ionization Sensor) process for concurrent assessment of methanol (MTL), ethyl acetate (ETL), triethyl amine (TTL), and dichloromethane (DRM) in rivaroxaban (RVN) bulk medication. MTL, ETL, TTL and DRM were separated using DB 624 column (3.0 μm thickness film, 75 m length x 0.53 mm internal diameter). The proposed GC-HS-FID method was authenticated for MTL, ETL, TTL and DRM analysis in RVN sample following ICH guidelines. A good linearity was gained over a range of solvents concentration 750.32 to 4501.94 ppm (MTL), 1249.67 to 7498.04 ppm (ETL), 1246.2 to 7477.17 ppm (TTL) and 150.92 to 905.54 ppm (DRM). The precision, specificity, accuracy, robustness data were documented in the within the acceptable limits. The GC-HS-FID process method can be regularly exploited for the intent of MTL, ETL, TTL and DRM analysis in RVN samples.