AN148: Determination of Bethanechol by Ion Chromatography.

Instrument Type: IC

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.

AN233: Determination of Galactosamine Containing Organic Impurities in Heparin by HPAE-PAD

Instrument Type: IC

In this application note, the organic impurities in heparin are determined by the HPAE-PAD method using the CarboPac PA20 column following the USP monograph method. This method was repeated using manually prepared eluents and an electrolytically generated eluent, with both eluent preparation options providing data that exceeds the system suitability requirements in the monograph.

AN181: Determination of Streptomycin and Impurities Using HPAE-PAD

Instrument Type: IC

Thermo Scientific Dionex ICS-3000 system with PAD is used to run the USP Compendial Method for the assay of streptomycin sulfate. Key performance parameters, including precision in determining streptomycin purity, limits of detection, linearity, and ruggedness, are shown to be consistent with normal method validation requirement. HPAE-PAD technology is demonstrated here for streptomycin A purity analysis and its feasibility for determinations in a fermentation broth. Finally, streptomycin A purity per the requirements of the ICH for new drug substances is evaluated.

AN267: Analysis of the Aminoglycoside Antibiotics Kanamycin and Amikacin Matches USP Requirements

Instrument Type: IC

The work shown here evaluates the HPAE-PAD assay method described in the USP monographs for kanamycin and amikacin8,9 and describes a revised HPAE-PAD method using a Dionex CarboPac™ MA1 column and disposable Au-on-polytetrafluoroethylene (PTFE) working electrodes for the analysis of kanamycin and amikacin. The described method provides good sensitivity, high sample throughput, and retention time reproducibility for kanamycin and amikacin.