HPLC同时测定复方硫酸新霉素药膜中盐酸丁卡因和克霉唑的含量

Simultaneous Determination of Tetracaine Hydrochloride and Clotrimazole in Compound Neomycin Sulfate Pellicles by HPLC

目的建立同时测定复方硫酸新霉素药膜中盐酸丁卡因和克霉唑含量的方法。方法采用HPLC,以Agilent HC-C18为色谱柱,流动相为甲醇-0.1%三乙胺溶液(用磷酸调pH至3.0)(85∶15),盐酸丁卡因和克霉唑的检测波长分别为311 nm和227 nm,流速0.8 mL.min 1,柱温20℃,进样20μL。结果盐酸丁卡因在2.5～50.0 mg.L 1内,峰面积与浓度呈良好的线性关系(r=0.999 5),平均回收率为99.3%,RSD=0.99%(n=9);克霉唑在5.33～106.5 mg.L 1内峰面积与浓度呈良好的线性关系(r=0.999 5),平均回收率为99.8%,RSD=1.28%(n=9)。结论本法简便、准确、重复性好,可用于复方硫酸新霉素药膜中盐酸丁卡因和克霉唑的含量测定。

OBJECTIVE To establish an HPLC method for simultaneous determination of tetracaine hydrochloride and clotrimazole in compound neomycin sulfate pellicles. METHODS An HPLC method was adopted. The column was Agilent HC-C18, the mobile phase was a mixture of methanol-0.1% triethylamine solution（adjusted to pH 3.0 with phosphoric acid） （85 ： 15）, the detection wavelength was 311 nm and 227 nm for tetracaine hydrochloride and ~lotrimazole, respectively, the flow rate was 0.8 mL-min-1, the column temperature was maintained at 20 ~C, and the injection volume was 20 μL. RESULTS The linear range of tetracaine hydrochloride was 2.5-50.0 mg-L-1（r=0.999 5）, and the average recovery was 99.3%, RSD=0. 99% （n=9）. The linear range of clotrimazole was 5.33-106.5 mg·L^-1（r=0.999 5）, and the average recovery was 99.8%, RSD= 1.28% （n=9）. CONCLUSION The method is simple, accurate, reproducible, and suitable for the simultaneous determination of tetracaine hydrochloride and clotrimazole in compound neomycin sulfate pellicles.