Simultaneous determination of insulin and its analogues in pharmaceutical formulations by micellar electrokinetic chromatography

• A MEKC method is proposed to identify human insulin and its five analogues.
• The major degradation product of each insulin can also be separated.
• The CE method is validated for the quantification of human insulin.
• The quality control of several pharmaceutical formulations has been performed.

A simple and efficient MEKC method was developed to simultaneously determine human insulin, its five analogues, the main degradation products and the excipients usually present in injection formulations. A very fast method with a total analysis time of 3 min was then successfully validated for the analysis of human insulin and the quality control of commercial formulations was carried out.