Determination of protamine peptides in insulin drug products using reversed phase high performance liquid chromatography

This paper describes the establishment and validation of a reversed phase HPLC (RP-HPLC) method for determination of protamine peptides in protamine sulphate raw material and insulin drug products, discusses the analytical results obtained for a number of protracted insulin formulations and the potential of the method in connection with protamine sulphate raw material and final drug product quality control. (c) 2004 Elsevier B.V. All rights reserved.