HPLC法测定茶碱脉冲控释微丸胶囊中主药的含量

目的:建立以高效液相色谱法测定茶碱脉冲控释微丸胶囊中茶碱含量的方法。方法:色谱柱为Diamonsil C18,流动相为甲醇-水(35∶65),流速为1.0mL·min-1,检测波长为272nm,进样量为20μL。结果:茶碱检测浓度的线性范围为5～40μg·mL-1(r=0.9999);平均回收率为100.55%,日内及日间RSD均小于1.2%。结论:本方法简单可行,结果准确可靠,可用于该制剂的含量测定。

Determination of Theophylline in Pulsatile Controlled - release Pellets Capsule of Theophylline by HPLC

OBJECTIVE： To establish a HPLC method for the determination of theophylline in pulsatile controlled - re- lease pellets capsule of theophylline. METHODS： The determination was performed on a Diamonsil C18 column with the mobile phase consisted of methanol water （35 ： 65） at a flow rate of 1.0 mL · min -1. The detection wavelength was set at 272 nm and the injection volume was 20μL. RESULTS： The linear range of theophylline was 5--40μg · mL- 1 （r - 0.999 9） with an average recovery rate of 100.55%. Both the intra- day RSD and the inter- day RSD were less than 1.2%. CONCLUSION： The method is accurate, reliable, simple and feasible, and it is applicable for the content determination of this preparation.