RP-HPLC测定硫鸟嘌呤片的含量及有关物质

Determination of Tioguanine and Its Related Substances by RP-HPLC

目的建立反相高效液相色谱法测定硫鸟嘌呤片的含量及有关物质。方法采用AltimaC18色谱柱,以0.05mol·L-1磷酸二氢钠溶液(pH3.0)为流动相,柱温为35℃;检测波长248nm;流速1.0mL.min-1。结果硫鸟嘌呤在8～120mg·L-1内线性关系良好(r=0.9999),回收率为99.27%。鸟嘌呤在0.1～40mg·L-1内线性关系良好(r=0.9999),最低检测限为0.12mg·L-1,回收率为100.23%。结论本方法准确、灵敏,精密度高、专属性强,可用于硫鸟嘌呤片含量及有关物质的测定。

OBJECTIVE To establish a reversed-phase high performance liquid chromatography （RP-HPLC） method for the determination of the tioguanine tablet and its related substances. METHODS The analytical column was Altima C18 and the mobile phase was 0.05 mol.L^-1 sodium dihydrogen phosphate acid （pH 3.0）. The column temperature was maintained at 35℃. The detection wavelength was set at 248 nm. The flow rate was 1.0 mL-min^-1. RESULTS Tioguanine was linear in the range from 8 to 120 mg.L^-1 （r=0.999 9）. The average recoveries were 99.27%. Guanine was linear in the range of 0.1-40 mg.L^-1 （r=0.999 9）. The limit of detection was 0.08 mg.L^-1. The average recoveries were 100.23%. CONCLUSION The method was proved to be accurate, sensitive and precise and showed highly specific. It can be applied for the content assay, as well as the related substances of tioguanine tablet.