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目的建立测定纳米纤维眼用膜剂中地塞米松棕榈酸酯含量的高效液相色谱法。方法采用岛津LC-20A型高效液相色谱仪,色谱柱为Diamosil C18(150 mm×4.6 mm,5μm),柱温40℃,流速:1 mL·min 1,流动相为100%甲醇,检测波长239 nm,进样量20μL。结果地塞米松棕榈酸酯浓度在0.1~5 g·mL 1内线性关系良好(r=0.999 5),日内精密度和日间精密度RSD均<2%(n=5),平均绝对回收率99.89%,RSD为1.15%(n=15)。结论本方法简便易行,重复性好,灵敏度高,结果准确可靠,适用于纳米纤维眼用膜剂中地塞米松棕榈酸酯含量测定。
Objective To establish a HPLC method for the determination of dexamethasone palmitate in nanofiber ophthalmic preparations. Methods Shimadzu LC-20A high performance liquid chromatograph was used. The column was Diamosil C18 (150 mm × 4.6 mm, 5 μm). The column temperature was 40 ℃, the flow rate was 1 mL · min 1 and the mobile phase was 100% Wavelength 239 nm, injection volume 20μL. Results The dexamethasone palmitate had a good linearity (r = 0.999 5) within the range of 0.1-5 g · mL -1. The intra-day and intra-day precision RSDs were less than 2% (n = 5) 99.89%, RSD 1.15% (n = 15). Conclusion The method is simple, reproducible, sensitive and accurate. It is suitable for the determination of dexamethasone palmitate in nanofiber ophthalmic preparations.