HPLC法同时测定Cervitec凝胶剂中醋酸氯己定和麝香草酚含量

Simultaneous determination of chlorhexidine and thymol in Cervitec Gel Preparations by HPLC

目的 Cervitec是一种治疗牙本质敏感的国外进口凝胶制剂，建立高效液相色谱法测定Cer vitec涂剂中醋酸氯己定和麝香草酚含量的分析法，为其质量控制提供手段。方法色谱柱：HypersilODS（51μm，4．0×250mm）；流动相为甲醇：水（含0．01mol·L^-1KH2P04和0．05mol·L^-1三乙胺，用磷酸调pH至2．8）=65：35；流速为1．0ml·min^-1温30℃；醋酸氯己定和麝香草酚检测波长分别为254nm和274nm。结果 醋酸氯己定和麝香草酚线性范围分别为1．0～50．0μgmL^-1（r=0．9996）和5．0～50．0μg·mL^-1（r=0．9991），Cervitec中醋酸氯己定和麝香草酚含量测定的RSD均小于2％。结论 本法简便，快速，准确。

OBJECTIVE Cervitec, imported from foreign, is a kind of gel preparations. To develop a high performance liquid chromatography （HPLC） method for the simultaneous determination of thymol and chlorhexidine acetate （CHa） so that it can provide a tool for the quality control of Cervitec preparations. METHODS The method depended on the separation of both drugs by high performance liquid chromatography using Hypersil ODS （5μm, 4. 0 × 250mm） column with a mobile phase consisting of methanol-water （concluding 0. 01 M KH2P04 and 0. 05M triethylamine, adjusted to 2. 8 with phosphoric acid） （65： 35, V/V） at a flow rate of 1.0 ml · min ^-1 with detection at 254nm for CHa and 274nm for thymol. RESULTS Using the presented HPLC method, the linear ranges were 1.0： 50. 0 μg·mL^-1 （r = 0. 9996） and 5.0： 50. 0μg·mL^-l（r = 0. 9991） for CHa and thymol, respectrively. The relative standard deviations for the determination of both CHa and thymol in Cervitec froms were below 2% . CONCLUSION The presented method showed good linearity, reproducibility and precision and were suitable for the simultaneous assays of thymol and CHa in Cervitec pharmaceuticals.