HPLC法测定复方庆大霉素膜中盐酸丁卡因和醋酸地塞米松的含量及含量均匀度

目的:建立高效液相色谱法同时测定复方庆大霉素膜中盐酸丁卡因和醋酸地塞米松的含量及含量均匀度。方法:色谱柱为Waters Sunfire C18(4.6 mm×150 mm,5μm),流动相为1%三乙胺溶液(冰醋酸调节pH至7.0)-甲醇(35∶65),检测波长为240 nm,柱温25℃,流量1.0 mL.min-1。结果:盐酸丁卡因在80.54～1006.80μg.mL-1范围内线性关系良好(r=1),平均模拟处方回收率为101.0%,RSD为0.42%;醋酸地塞米松在2.36～29.51μg.mL-1范围内线性关系良好(r=1),平均模拟处方回收率为100.6%,RSD为0.38%。结论:方法快速简便,准确可靠,重复性好,可用于复方庆大霉素膜的质量控制。

Determination of Tetracaine Hydrochloride and Dexamethasone Acetate in Compound Gentamicin Pellicles and Content Uniformity

Objective： To establish an HPLC method for the determination of tetracaine hydrochloride and dexamethasone acetate in Compound Gentamiein Pellicles. Methods： The Waters Sunfire CIs column （4. 6 mm × 150 mm,5 μm）was used with a mobile phase of triethylamine （ adjust pH value to 7. 0 with acetic acid） -methanol（ 35 ： 65 ）, the detection wavelength was set at 240 nm, the the flow rate was 1.0 mL · min -1 and column temperature was at 25 ℃. Results： The calibration curves of tetraeaine hydrochloride was linear in the range of 80. 54-1006. 80μg . mL -1 （ r = 1 ）, the average recovery was 101.0%, （ RSD = 0. 42% ） ; the calibration curves of dex- amethasone acetate was linear in the range of 2. 36-29. 51 μg · mL-1 （ r = 1 ） , the average recovery was 101.0% , （ RSD = 0. 38% ）. Conclusion ： The method is simple, reliable and reproducible and can be used effectively for the quality control of Compound Gentami- tin Pellicles.