Gradient liquid chromatographic method for determination of chlorhexidine and its degradation products in bulk material.
A liquid chromatographic method was developed for determination of chlorhexidine and its degradation products in unformulated drug substance. A nonlinear gradient from 80% 0.1M ammonium acetate buffer, pH 5.0, to 20% buffer over 90 min (balance is acetonitrile) is applied to a 3 microns octadecylsilane bonded-phase column. The drug and some of its degradation products are determined at 230 nm. Of 11 previously identified degradation products, 9 are determined with good precision (relative standard deviation of peak area is < 2%).
Doub
W H
WH
U.S. Food and Drug Administration, Division of Drug Analysis, St. Louis, MO 63101-2045, USA.
Ruhl
D D
DD
Hart
B
B
Mehelic
P R
PR
Revelle
L K
LK
D002710:Chlorhexidine / Q000032:analysis*; D002853:Chromatography, Liquid; D004202:Disinfectants / Q000032:analysis*; D015203:Reproducibility of Results
D004202:Disinfectants; D002710:Chlorhexidine