论文部分内容阅读
目的:建立维地西林涂剂中盐酸丁卡因的质量控制方法,保障安全用药。方法:采用高效液相色谱法测定,色谱柱:Diamonsil-C18柱(250 mm×4.6 mm,5μm);流动相:甲醇-0.4%三乙胺溶液(用稀磷酸调节pH值至3.0)(55∶45);流速1.0 mL/min;检测波长311 nm;进样量20μL;柱温30℃。结果:盐酸丁卡因在0.494～12.350μg/mL范围内线性关系良好,线性方程为Y=0.065X+0.0086(r=0.9995),平均回收率为99.8%,RSD=0.96%(n=6)。结论:本研究所建方法快速、简便、重现性好,适用于维地西林涂剂中盐酸丁卡因的含量测定。
OBJECTIVE: To establish a quality control method for tetracaine hydrochloride in Viti Xilin coating to ensure safe medication. Methods: High performance liquid chromatography (HPLC) was used. The column was Diamonsil-C18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol-0.4% triethylamine (adjusted to pH 3.0 with dilute phosphoric acid) : 45); flow rate 1.0 mL / min; detection wavelength 311 nm; injection volume 20 μL; column temperature 30 ℃. Results: The linearity of tetracaine hydrochloride in the range of 0.494 ~ 12.350μg / mL was good, the linear equation was Y = 0.065X + 0.0086 (r = 0.9995), the average recovery was 99.8%, RSD was 0.96% . Conclusion: The method proposed in this study is rapid, simple and reproducible. It is suitable for the determination of tetracaine hydrochloride in Vitipecilin coating.