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.
Hvass
A
A
Novo Nordisk A/S, Novo Alle, 2880 Bagsvaerd, Denmark. aahv@novonordisk.com
Skelbaek-Pedersen
B
B
D002851:Chromatography, High Pressure Liquid / Q000379:methods; D007328:Insulin / Q000032:analysis*; D010455:Peptides / Q000032:analysis*; D011479:Protamines / Q000032:analysis*
D007328:Insulin; D010455:Peptides; D011479:Protamines