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目的:建立他克莫司滴眼液的质量控制方法,并考察其稳定性。方法:根据中国药典2005年版眼用制剂项下规定建立他克莫司滴眼液的质量控制方法,用高效液相色谱法测定他克莫司的含量,采用经典恒温加速试验法考察该制剂对热的稳定性。结果:他克莫司在6.25~200mg.L-1范围内线性关系良好(r=0.999 9),平均回收率为98.94%,RSD为0.89%(n=8),方法重复性的RSD为1.28%(n=6),他克莫司滴眼液对热的稳定性较差,预测25℃贮存有效期为46.68d,而4℃贮存有效期约2.55年。结论:采用高效液相色谱法测定他克莫司的含量简便、精密、可行。他克莫司滴眼液需低温保存。
Objective: To establish a quality control method of tacrolimus eye drops and investigate its stability. Methods: According to the Chinese Pharmacopoeia 2005 edition ophthalmic preparations under the provisions of the establishment of tacrolimus eye drops quality control methods, determination of tacrolimus content by high performance liquid chromatography, using classical thermostat accelerated test method to study the preparation of Thermal stability. RESULTS: Tacrolimus had a good linearity (r = 0.999 9) in the range of 6.25-200 mg.L-1 with an average recovery of 98.94% and a RSD of 0.89% (n = 8). The reproducibility of the method was 1.28 % (n = 6). The stability of tacrolimus eye drops on heat is poor. The shelf life at 25 ℃ is estimated to be 46.68 days, while the shelf life at 4 ℃ is about 2.55 years. Conclusion: The determination of tacrolimus by HPLC is simple, precise and feasible. Tacrolimus drops should be stored at low temperature.