论文部分内容阅读
目的建立测定他克莫司滴眼液含量的高效液相色谱法。方法采用Diamonsil C18(250mm×4.6mm,5μm)为色谱柱;流动相为乙腈-水-磷酸(600:400:1);流速为2.0ml/min;检测波长为215nm;柱温为50℃。结果他克莫司在6.25~200mg/L浓度范围内线性关系良好(r=0.9999),平均回收率为99.68%,RSD为0.78%,方法重现性的RSD为1.28%(n=6)。结论该方法简便、快速、灵敏,可用于该制剂的质量控制。
Objective To establish a high performance liquid chromatographic method for the determination of tacrolimus eye drops. Methods Diamonsil C18 (250 mm × 4.6 mm, 5 μm) was used as the column. The mobile phase consisted of acetonitrile - water - phosphoric acid (600: 400: 1). The flow rate was 2.0 ml / min. The detection wavelength was set at 215 nm. Results Tacrolimus had a good linearity (r = 0.9999) at a concentration range of 6.25-200mg / L with an average recovery of 99.68% and a RSD of 0.78%. The reproducibility of the method was 1.28% (n = 6). Conclusion The method is simple, rapid and sensitive and can be used for the quality control of the preparation.