目的 建立测定他克莫司眼用乳状液含量的高效液相色谱法。方法 采用Diamonsil C18（4.6 mm×250 mm，5 μm）为色谱柱；流动相为乙腈-水-磷酸（600∶400∶1）；流速为2.0 mL·min-1；检测波长为215 nm；柱温为50 ℃。结果 他克莫司在6.25～200 mg·L-1内线性关系良好（r=0.999 9），平均回收率为99.35％，RSD为0.81％，方法重现性的RSD为1.04％（n=6）。结论 本方法专属性强、操作简便、结果准确，可用于测定他克莫司眼用乳状液的含量。
Abstract
OBJECTIVE To establish a HPLC method for the content determination of tacrolimus ophthalmic emulsion. METHODS The separation was performed on a Diamonsil C18 column（4.6 mm×250 mm，5 μm）. The mobile phase consisted of acetonitrile- water- phosphonic acid (600∶400∶1) at the flow of 2.0 mL·min-1. The detection wavelength was at 215 nm and column temperature was 50 ℃. RESULTS The calibration curve of tacrolimus was linear within the concentration range of 6.25～200 mg·L-1（r＝0.999 9）. The average recovery of tacrolimus was 99.35% (RSD=0.81%), and the RSD of the repeatability test was 1.04% (n=6). CONCLUSION The method is simple, quick and specific. It can be used to determine the content of tacrolimus ophthalmic emulsion.
关键词
高效液相色谱法 /
他克莫司 /
眼用乳状液
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Key words
HPLC /
tacrolimus /
ophthalmic emulsion
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参考文献
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