A Method for the Qualitative and Quantitative Determination of the Amino Acid Composition of Pharmaceutical Products

The United States Pharmacopeial Convention (USP), European Pharmacopoeia (Ph. Eur.) and Japanese Pharmacopoeia (JP) define requirements for the qualitative and quantitative composition of medicines. These pharmacopeias also outline the analytical methods to be carried out on pharmaceutical products as well as the substances and materials used in their production.
 
This paper outlines the development of a liquid chromatography method for simultaneous determination of approximately 20 amino acids in simple and complex mixtures that complies with the system suitability requirements of the Ph. Eur. general chapter (2.2.56).