环孢素眼用乳剂的制备和含量测定

Preparation and Determination of Cyclosporine Ophthalmic Emulsion

目的研究环孢素眼用乳剂的制备,建立含量测定方法。方法采用高压均质机制备环孢素眼用乳剂,以高效液相色谱法(HPLC)测定环孢素含量,Gemini C_(18)柱为色谱柱;流动相:乙腈∶水∶甲醇∶磷酸(550∶400∶50∶0.5,v/v),柱温:70℃,流速:1 m L·min^(-1),紫外检测波长:210 nm。结果在0.099 5~0.278 6 mg·m L^(-1)范围内,环孢素峰面积和质量浓度呈良好的线性关系,平均回收率为99.1%,RSD为0.84%。结论该处方和制备工艺可行,含量测定方法准确、可靠。

OBJECTIVE To establish the procedures to produce cyclosporine ophthalmic emulsion and a method for the determination. METHODS Cyclosporine ophthalmic emulsion was prepared by a high-pressure homogenization. The separation was performed on Gemini C18 column,the mobile phase was acetonitrile-water-methanol-phosphoric acid（ 550 ∶ 400 ∶ 50 ∶ 0. 5,v / v）,with the flow rate of 1m L·min^-1,the detection wavelength was at 210 nm and column temperature was 70 ℃. RESULTS The calibration curve of cyclosporine ophthalmic emulsion was linear within the conventration range of 0.099 5-0.278 6 mg·mL^-1.The average recovery rate of cyclosporine ophthalmic emulsion was 99. 1%（ RSD = 0. 84%）. CONCLUSION The formulation and preparation technology is feasible,and the determination method is accurate and reliable.