HPLC测定茶碱类口服固体制剂中的茶碱

Determination of theophylline of theophylline oral solid preparations by HPLC

目的以乙醇-水为流动相,采用HPLC法测定茶碱类口服固体制剂(氨茶碱片、氨茶碱缓释片、茶碱缓释片、茶碱缓释胶囊等)中茶碱的含量。方法采用Welch Ultimate C18色谱柱(250 mm×4.6 mm,5μm),以乙醇-水(10:90)为流动相,流速1.0 mL·min^(-1),柱温40℃,检测波长272 nm。结果回归方程为:Y=30.5045X-6.1468(r=0.9999),线性范围为21.20~212.00μg.mL^(-1);氨茶碱片、氨茶碱缓释片、茶碱缓释片、茶碱缓释胶囊等的平均回收率为99.33%~99.77%(n=6),RSD为1.08%~1.62%,定量限为0.02μg·mL^(-1);供试品溶液在48 h内稳定,RSD为0.79%~1.30%(n=7)。结论以水-乙醇为流动相的HPLC法简单、快速、准确,适用于茶碱类口服固体制剂中茶碱的含量测定;流动相和溶剂采用乙醇-水,提供了一种环保和健康的实验方法,建议推广应用。

OBJECTIVE To determine content of theophylline in theophylline oral solid preparations(aminophylline tablets,aminophylline sustained-release tablets,theophylline sustained-release tablets and theophylline sustained-release capsules)by HPLC with ethanol-water as mobile phase.METHODS Analysis was performed on a Welch Ultimate C18 column(250 mm×4.6 mm,5μm),the mobile phase was ethanol-water(10:90),the flow rate was 1.0 mL·min^(-1),the column temperature was 40℃,and the detection wavelength was 272 nm.RESULTS The regression equation,linear ranges of calibration curves,correlation coefficient were respectively Y=30.5045X-6.1468,21.20-212.00μg·mL^(-1),and r=0.9999.The average recovery was 99.33%-99.77%,and RSD(n=6)was 1.08%-1.62%.The sample solutions were stable in 48 h,and the RSD(n=7)was 0.79%-1.30%.The LOQ was 0.02μg·mL^(-1).CONCLUSION The established method is simple,rapid,accurate and suitable for the determination of theophylline of theophylline oral solid preparations where water-ethanol is used as mobile phase,which has provided an environmental and healthy experimental method,and it is suggested to be popularized.