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目的建立他克莫司眼用乳液的质量控制方法。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眼用乳液的质量控制方法,用高效液相色谱法测定他克莫司的含量,观察家兔眼部刺激性,并对制剂的稳定性进行考察。结果他克莫司在6.25～200μg·mL-1浓度内线性关系良好(r=0.9999),平均回收率为99.83%,RSD为0.59%,方法重现性的RSD为1.04%(n=6)。滴眼后无刺激性,而且稳定性相对较好。结论本方法专属性强、操作简便、结果准确,可用于他克莫司眼用乳液的质量控制。
Objective To establish a quality control method of tacrolimus ophthalmic emulsion. Methods According to the Chinese Pharmacopoeia 2005 edition of ophthalmic preparations under the provisions of the establishment of tacrolimus ophthalmic emulsion quality control method using high performance liquid chromatography determination of tacrolimus content observed rabbits eye irritation and preparation The stability of the inspection. Results Tacrolimus had a good linearity (r = 0.9999) at a concentration of 6.25-200 μg · mL-1 with an average recovery of 99.83% and a RSD of 0.59%. The reproducibility of the method was 1.04% (n = 6) . No eye irritation, and the stability is relatively good. Conclusion This method is specific, easy to operate and accurate. It can be used for the quality control of tacrolimus ophthalmic emulsion.