[HPLC determination of insulin and its related substances in insulin powder for inhalation].
OBJECTIVE
To determine insulin and its related substances in insulin powder for inhalation by reversed phase high performance liquid chromatography method.


METHODS
The initial mobile phase was solution A (0.1% trifluoroacetic acid-acetonitril 70:30) and changed to solution B (0.1% trifluoroacetic acid-acetonitril 60:40) in 30 minutes. The flow rate was 2.0 mL.min-1, the column temperature was 30 degrees C, the wave length was 280 nm, the injected volume was 20 microL.


RESULTS
Insulin was well separated from other peaks induced in different conditions. There was good linear relationship between the amount of insulin and its peak area, the RSD was 1.1%, the insulin solution for determination was stable in 12 hours, and the quantity detected was near the added.


CONCLUSIONS
The method is simple and accurate to detect insulin and its related substances in insulin and its preparations.
Chen
Xi-jing
XJ
Department of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, Nanjing 210009, China.
Zhu
Jia-bi
JB
Wang
Guang-ji
GJ
Zhou
Ming-xia
MX
Xu
Yue-ning
YN
D000280:Administration, Inhalation; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D007328:Insulin / Q000008:administration & dosage / Q000032:analysis*; D011208:Powders / Q000032:analysis
D007328:Insulin; D011208:Powders