Objective:To study the suitability of HPLC method for determination of impurities Insulin lispro as well as identity of Insulin
and Insulin analogs.Methods:Chromatographic conditions included Vydac C 18 column and the mobile phase consisting of a mixture of
acetonitrile-sulfate solution(0 02 mol·L -1 ,pH 2 3).Gradient program elute isocratically or elute linearly.Detection wavelength was at 214 nm.The flow rate was 0 8 or 1 mL·min -1 .The temperature of column was 40 ℃.The Zorbax GF250 column was used,mobile phase:Ammonium phosphate buffer-acetonitrile(65∶35),flow rate: 0 5 mL·min -1 .Results:The
peptide mapping,RP-HPLC and high performance size exclusive chromatography(HPSEC) chromatograms of Insulin and Insulin analogs were obtained.Conclusion:These methods are found to be effective for identity of Insulin and Insulin analogs,suitable for determination of impurities Insulin lispro.This paper provides the scientific basis for the quality control of Insulin analogs products.