QuEChERS-UPLC法同时测定澳乐君乳膏中盐酸苯海拉明和醋酸地塞米松的含量  

Simultaneous Determination of Diphenhydramine Hydrochloride and Dexamethasone Acetate in Aolejun Cream by Qu ECh ERS-UPLC

作　　者：王舒 徐丹洋 庄晓庆 WANG Shu;XU Dan-yang;ZHUANG Xiao-qing(Nantong Food and Drug Control Center,Nantong 226006,China)

机构地区：[1]南通市食品药品监督检验中心,江苏南通226006

出　　处：《海峡药学》2022年第11期65-68,共4页Strait Pharmaceutical Journal

摘　　要：目的 建立QuEChERS前处理方式-超高效液相色谱(QuEChERS-UPLC)法,同时测定澳乐君乳膏中的盐酸苯海拉明和醋酸地塞米松的含量。方法 样品经乙腈提取,改进的QuEChERS法净化,采用Waters Acquity UPLC BEH C_(18)(2.1 mm×150 mm, 1.7μm)色谱柱分离;以己烷磺酸钠溶液(用冰醋酸调节pH值至3.3)-乙腈(48∶52)为流动相,流速为0.2 mL·min^(-1),检测波长为230 nm,柱温为30℃。结果 盐酸苯海拉明质量浓度在82.71~413.57μg·mL^(-1)范围内呈现良好线性关系,回归方程为Y_(1)=4.794X+8.985(r=0.9999),平均加样回收率为99.29%,RSD为1.07%(n=9)。醋酸地塞米松在质量浓度在1.37~13.70μg·mL^(-1)范围内呈现良好线性关系,回归方程为Y_(2)=11.56X-0.266(r=0.9999),平均加样回收率为99.08%,RSD为1.50%(n=9)。结论 该方法操作简单、重现性良好,检测准确,适用于控制澳乐君乳膏的质量。OBJECTIVE To establish a QuEChERS-UPLC method for simultaneous determination of diphenhydramine hydrochloride and dexamethasone acetate in Aolejun cream.METHODS The analytes were extracted by acetonitrile, and then the extracts were purified using an improved QuEChERS method.Chromatographic separation was achieved on a Waters Acquity UPLC BEH C_(18) column(2.1 mm×150 mm, 1.7 μm) by using sodium hexane sulfonate solution(adjust the pH value to 3.3 with glacial acetic acid)-acetonitrile(48∶52) as the mobile phase.The flow rate was 0.2 mL·min^(-1),the detection wavelength was 230 nm and the column temperature was 30 ℃.RESULTS The mass concentration of diphenhydramine hydrochloride was 82.71-413.57 μg·mL^(-1).The regression equation was Y_(1)=4.794 X+8.985(r=0.9999),the average recovery was 99.29%,and the RSD was 1.07%(n=9).The mass concentration of dexamethasone acetate showed a good linear relationship in the range of 1.37-13.70 μg·mL^(-1)respectively.The regression equation was Y_(2)=11.56 X-0.266(r=0.9999).The average recovery was 99.08% and RSD was 1.50%(n=9).CONCLUSION The method is simple, reproducible and accurate, which can be used to control the quality of Aolejun cream.

关 键 词：QuEChERS-UPLC法 盐酸苯海拉明 醋酸地塞米松 含量测定 

分 类 号：R927[医药卫生—药学]