气相色谱法测定复方达克罗宁薄荷脑润肤止痒水中薄荷脑含量

Determination of Menthol in Compound Dyclonine Hydrochloride and Menthol Antipruritic Solution by Gas Chromatography

目的建立测定复方达克罗宁薄荷脑润肤止痒水中薄荷脑含量的气相色谱法。方法色谱柱为Agilent DB-Waxetr毛细管柱(30 m×0.53 mm,1.0μm),采用分流进样方式,分流比为10∶1,进样口温度和柱温分别设定为250℃和120℃,以氢焰离子化检测器作为检测气,检测器温度设定为250℃,载气为氮气,柱前压69.9 MPa,流速1.5 mL/min。结果薄荷脑质量浓度线性范围为0.335 6～1.678 g/L,r=0.999 8,平均回收率为99.64%,RSD为0.55%(n=6)。结论所用方法操作简便、准确、灵敏度高、重复性好,可用于测定制剂中薄荷脑的含量。

Objective To develop a content determination method for the determination of menthol in the Compound Dyclonine Hydrochloride and menthol antipruritic solution.Methods The method of GC was applied to determine the content of menthol.The separation was performed on an Agilent DB-WAX capillary column（30 m×0.53 mm,1.0 μm）.Split injection with a split ratio of 10 ∶1 was used.Injector temperature and column temperature was set at 250 ℃and 120 ℃,respectively.Hydrogen flame ionization detector（FID） was used as the detector with temperature 250 ℃.The carrier gas was nitrogen with a flow rate of 1.5 mL/min.Column inlet pressure was 69.9 Mpa.Results The calibration curve was linear within the concentration range of 0.335 6-1.678 g/L,r=0.999 8,the average recovery rate was 99.64%,RSD=0.55%（n=6）.Conclusion The developed method is simple and accurate and suitable for the determination of the menthol content in the compound dyclonine hydrochloride and menthol antipruritic solution.