气相色谱法同时测定复方醋酸地塞米松乳膏中樟脑和薄荷脑的含量

Simultaneous determination of camphor and menthol in Compound Dexamethasone Acetate Cream by GC

目的：建立毛细管气相色谱法同时测定复方醋酸地塞米松乳膏中樟脑、薄荷脑两组分的含量。方法：以水杨酸甲酯为内标物，用无水乙醇作溶剂，60℃水浴加热提取样品，Agilent HP—INNOWAX（30m×0．320mm×0．25μm）为色谱柱；载气为氮气，分流比25．0：1，流速1．5mL／min；柱温145℃，进样口温度200℃，氢火焰离子化检测器（FID），检测温度250℃；进样量0．6μL。结果：樟脑、薄荷脑浓度分别在0．303—3．030g／L（r=0．9999）和0．306．3．060g／L（r=0．9999）范围内与内标物峰面积比呈良好线性关系，高、中、低3个浓度的平均回收率樟脑为100．6％，100．2％，99．7％：RSD为0．58％，0．65％，0．88％（n=3）。薄荷脑为100．3％，99．8％，97．8％；RSD为0．43％，0．78％，1．0％（n=3）。结论：方法简便、快速，结果准确，可作为复方醋酸地塞米松乳膏的质控方法。

To establish the capillary GC method for separating and determining both camphor and men- thol in Compound Dexamethasone Acetate Cream. METHODS： The methyl salicylate was used as internal substance and the sample solution was prepared by extracting with anhydrous ethanol at 60 ℃. The GC test conditions consisted of Agilent HP-INNOWAX （30 m×0. 320 mm ×0.25 μm） as the stationary phase, nitrogen as the carrier gas, split ratio of 25.0 ： 1. The flow rate was 1.5 mL/min, column temperature was at 145℃, inlet temperature was 200 ℃, FID detection was 250 ℃, injection volume was 0.6 μL. RESULTS ： The linearities of camphor and menthol were good, in the range of 0. 303 - 3. 030 g/L with r = 0. 999 9 for camphor and in the range 0. 306 - 3. 060 g/L with r = 0. 999 9 for menthol. The average recoveries of high, middle and low three concentrations for menthol were 100.6%, 100.2%, 99.7% ; RSD was 0.58%, 0.65%, 0.. 88% and for camphor were 100.3%, 99.8%, 97.8%; RSD was 0.43%, 0.78%, 1.0%. CONCLUSION： This method is convenient, rapid, accurate and reproducible, and can be used for quality control of Compound Dexamethasone Acetate Cream.