RP-HPLC测定舒他兰锌及其有关物质

Determination of Suftalan Zinc and Its Related Substances by RP-HPLC Assays

目的建立反相高效液相色谱法测定抗癌光敏剂舒他兰锌（Suftalan zinc）含量及有关物质。方法采用SHIMADZU SHIM-PACK VP-ODS色谱柱（4．6mm×150mm，5μm），以四氢呋喃-甲醇-N，N二甲基甲酰胺-水-三乙胺（150：105：755：1000：1．4，磷酸调pH值6．5-7．0）为流动相，流速1．0mL·min^-1，紫外可见检测器于677nm测定。结果RP-HPLC测定的线性范围为20．0～120．1mg·L^-1，相关系数r=0．9999；最低检测限为0．048μg；样品溶液至少在3d内稳定；日内精密度（RSD=0．70％）良好。结论采用反相高效液相色谱法测定抗癌光敏剂（舒他兰锌）含量及有关物质方法简便，结果准确。

OBJECTIVE To establish a RP-HPLC method for the determination Suftalan zinc and its related substances. METHODS A separation was performed on a SHIM-PACK VP-ODS column（4.6mm×150mm, 5μm） and mobile phase was THF-CH3OH-DMF-H2O-TEA（150：105：755：1 000： 1.4, adjust pH to 6.5-7.0 using H3PO4） with a flow rate of 1 mL·min^-1. The detective wavelength was 677 nm. RESULTS The calibration curve was linear in the concentration range of 20.0-120.1 mg·L^-1 （r=0.999 9）. The LOD was 0.048 μg. The sample solution was stable within 3 d, intra-day validation （RSD=0.70%） was good. CONCLUSION The method to determine the content and its related substances of Suftalan zinc by RP-HPLC is easy to operate and the results of the determination is accurate.