Clavulanic acid is a potent beta-lactamase inhibitor. 2-ethylhexanoic acid is a potential impurity. This work presents a simpler IC method using a Reagent-Free Ion Chromatography (RFIC) system with suppressed conductivity detection and IonPac AS11 column for the detection and quantification of 2-ethylhexanoic acid. Results for LOD/LOQ, linear calibration range, spike recovery, retention time precision, and peak area precision determinations show that IC is an accurate and reproducible technique to determine 2-ethylhexanoic acid in clavulanate below the 0.8% acceptance criteria.

The antiretroviral drug tenofovir is in formulation given as the prodrug tenofovir disoproxil fumarate (TDF) in combination with the nucleoside reverse-transcriptase inhibitor emtricitabine. Here we show the impurity profiling of an active pharmaceutical ingredient with the Thermo Scientfic Vanquish Flex UHPLC system. The simultaneous separation of early-eluting polar compounds and later-eluting nonpolar compounds is achieved by applying a ternary gradient with the quaternary Vanquish F pump using a Thermo Scientific Accucore aQ column.

Bethanechol chloride is a quaternary ammonium compound that is structurally and pharmacologically related to acetylcholine. A method in the USP 24 NF 19 recently proposed that the gravimetric assay for bethanechol chloride be replaced with a more specific and rugged ion chromatography assay. The proposed method specifies the use of a Dionex IonPac CS14 separator column using methanesulfonic acid (MSA) eluent and suppressed conductivity detection. Here, we applied electrolytic on-line generation of MSA to optimize reproducibility, convenience, and method transfer between laboratories.

This application demonstrates the fast seaparation of four main compounds of the Stribild pill using the latest generation of UHPLC equipment. The highly efficient Thermo Scientific Accucore Vanquish C18+ column with 1.5 μm particles provides a fast separation of the main compounds and several impurities.

The Thermo Scientific HPLC system was applied for the analysis of active pharmaceutical ingredients (APIs) in a pain-relief medicine. The separation was performed on a Thermo Scientific Acclaim Mixed-Mode WAX-1 column with UV detection at 220 nm.