Doub W H, Ruhl D D, Hart B, Mehelic P R, Revelle L K
U.S. Food and Drug Administration, Division of Drug Analysis, St. Louis, MO 63101-2045, USA.
J AOAC Int. 1996 May-Jun;79(3):636-9.
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%).
开发了一种液相色谱法，用于测定未制剂化原料药中洗必泰及其降解产物。在90分钟内将流动相从80%的0.1M醋酸铵缓冲液（pH 5.0）非线性梯度变化至20%缓冲液（其余为乙腈），应用于3微米十八烷基硅烷键合相柱。在230nm波长处测定药物及其一些降解产物。在之前鉴定出的11种降解产物中，9种的测定具有良好的精密度（峰面积相对标准偏差<2%）。
