Development of Fast and Selective Analytical Methods of Pharmaceuticals and Herbal Medicines by High-Performance Liquid Chromatography and Capillary Electrophoresis

Abstract

Pharmaceuticals are essential for the medical treatment of various diseases. From the herbal medicines (crude drugs), synthetic medicines to biopharmaceuticals, to assure its efficacy and safety, the production procedures and the quality control methods of pharmaceuticals are important. These are strictly regulated by Good Manufacturing Practice (GMP) and various guidelines. The key is to develop the “Specifications and testing methods” of the pharmaceutical scientifically and rationally according to the production process. There are many testing items such as identity tests, purity tests, assay, etc. in “Specifications and testing methods”. Among them, assay and purity test are core testing items. Optical purity evaluation is required for the single enantiomer pharmaceutical. Chromatographic methods and its detection methods are useful for the purpose. High-performance liquid chromatography (HPLC), thin layer chromatography (TLC) and gas chromatography (GC) are commonly used because the target analyses are almost a mixture. In this review, results of the development of the quality evaluation methods of relatively low molecular pharmaceuticals and herbal medicines by HPLC and capillary electrophoresis (CE) we have been investigated are summarized.