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目的建立他克莫司眼用乳剂的含量测定方法,并考察其稳定性。方法采用Diamonsil C18分析柱(250mm×4.6mm,5μm),流动相为乙腈-水-磷酸(600∶400∶1,V/V/V),流速为2.0mL·min-1,检测波长为215nm,柱温为50℃。采用经典恒温加速试验法预测该制剂对热的稳定性。结果他克莫司在6.25～200mg·L-1浓度范围内线性关系良好(r=0.9999),平均回收率为(99.8±s0.8)%,RSD为0.59%,方法重现性的RSD为1.04%(n=6)。预测他克莫司眼用乳剂25℃贮存有效期为122.6d,而4℃贮存有效期约7.4年。结论该方法简便、精密、可行,他克莫司眼用乳剂需低温保存。
Objective To establish a method for the determination of tacrolimus ophthalmic emulsion and investigate its stability. Methods Diamonsil C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was acetonitrile-water-phosphoric acid (600:400:1, V / V / V) with a flow rate of 2.0 mL · min- The column temperature was 50 ° C. The classical thermostatic accelerated test method is used to predict the thermal stability of the preparation. Results Tacrolimus had a good linearity (r = 0.9999) in the range of 6.25 ~ 200 mg · L-1, with an average recovery of 99.8 ± 0.8% and a RSD of 0.59%. The reproducibility of the method was 1.04% (n = 6). It is predicted that the tacrolimus ophthalmic emulsion has a shelf-life of 122.6 days at 25 ° C and a shelf-life of about 7.4 years at 4 ° C. Conclusion The method is simple, accurate and feasible. The tacrolimus ophthalmic emulsion should be stored at low temperature.