HPLC法测定他克莫司胶囊的含量

Determination of tacrolimus capsules by HPLC

目的建立他克莫司胶囊含量的测定方法。方法采用高效液相色谱法，色谱柱为Kromasil 100-5C18柱（250mm×4．6mm，5μm），流动相为流动相：乙腈-水-磷酸（700：300：1），柱温为60℃，流速1．0ml·min^-1，检测波长为215nm；对3批他克莫司胶囊进行含量测定。结果他克莫司浓度在12．5～125mg·L^-1范围内，峰面积和浓度线性关系良好，平均回收率为98．8％（n=9），RSD=1．20％；3批样品中他克莫司含量分别为98．81％，98．67％，98．92％。结论该法测定他克莫司胶囊的含量，简便快捷，结果准确，重现性好，易于操作，可用于他克莫司胶囊含量的测定。

Aim To establish an assay method for taerolimus capsules. Method HPLC method was adopted, chromatographic column being Kromasil 100-5 C18 （ 250 mm × 4.6 mm,5μm） with column temperature at 60℃ , acetonitrile-water-phosphonic acid （ 700： 300： 1 ） used as mobile phase at the flow rate of 1.0 ml · min^-1 ,and detection wavelength being 215 nm. The assay for three batches of tacroli- mus capsules was determined. Result Tacrolimus capsules concentrations are within the range from 12.5 μg to 125 mg · L^-1. The linear correlation between peak areas and concentration is good with average recovery of 98.8% （n = 9） and RSD is 1.20%. The content for three batches of tacrolimus capsules are 98.81% ,98.67% and 98.92%, respectively. Conclusion The method is simple, accurate and well reproducible. It is easy to operate and suitable to determine the assay of tacrolimus capsules.