Ion Chromatography in USP-NF

摘要

Ionic methods of separation have been used in a variety of applications over several hundreds of years. However, the modern form of ion chromatography (IC) was introduced in 1975 by Small, et al. [1]. The technique, a form of high-performance liquid chromatography (HPLC), has since gained popularity in laboratories for the analysis of inorganic anions and cations, organic acids, carbohydrates, sugar alcohols, aminoglycosides, amino acids, proteins, peptides, glycoproteins and other types of molecules in environmental, agricultural, pharmaceutical, biotechnology, metal plating, power generation, semiconductor fabrication, and other industrial samples. IC-based methods, sometimes in conjunction with mass spectrometry or other hyphenated techniques, have been used in the analysis of active and inactive ingredients, excipients, degradation products, and impurities relevant to pharmaceutical and biotechnological drug quality. A detailed discussion of such applications is beyond the scope of this article. Here, we shall discuss application of ion chromatographic methods in the analysis of therapeutic products and their ingredients included in USP-NF monographs and general chapters, and their importance in setting standards for identity, strength (content), quality and purity of products and ingredients. For more in depth understanding of the principles, instrumentation and applications of IC, readers are encouraged to read the books and other publications on IC that provide in-depth review of this chromatographic technique [2-4].