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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 a method for the simultaneous determination of tetracaine hydrochloride and clotrimazole in compound neomycin sulfate film. Methods The mobile phase consisted of methanol-0.1% triethylamine (adjusted to pH 3.0 with phosphoric acid) (85:15) by HPLC on an Agilent HC-C18 column. The detection wavelength of tetracaine hydrochloride and clotrimazole were At 311 nm and 227 nm, the flow rate was 0.8 mL.min 1 and the column temperature was 20 ℃. Results The peak area and concentration of tetracaine hydrochloride showed a good linear relationship (r = 0.999 5) with an average recovery of 99.3% and a RSD of 0.99% (n = 9) in the range of 2.5-50.0 mg · L -1. There was a good linear relationship between the peak area and concentration of azole (r = 0.999 5). The average recovery was 99.8% with RSD = 1.28% (n = 9). Conclusion This method is simple, accurate and reproducible. It can be used for the determination of tetracaine hydrochloride and clotrimazole in the compound neomycin sulfate film.