CAJ | 학술논문

目的：建立高效液相色谱法测定盐酸托烷司琼中的有关物质。方法：采用agilent Extend C18色谱柱(5um，4.6*250mm)，磷酸盐缓冲液（取磷酸二氢钾6.8g，加水500ml使溶解，加三乙胺5ml，用水稀释至1000ml，用磷酸调节pH值至3.5）-乙腈（80：20）为流动相，流速为1.0ml/min，检测波长为284nm，柱温为30℃。结果：盐酸托烷司琼与其降解产物在该色谱条件下能够有效分离，检测限为2ng。结论：本方法简便、快速、灵敏、准确，可用于测定盐酸托烷司琼中的有关物质。
목적：건립고효액상색보법측정염산탁완사경중적유관물질。방법：채용agilent Extend C18색보주(5um，4.6*250mm)，린산염완충액（취린산이경갑6.8g，가수500ml사용해，가삼을알5ml，용수희석지1000ml，용린산조절pH치지3.5）-을정（80：20）위류동상，류속위1.0ml/min，검측파장위284nm，주온위30℃。결과：염산탁완사경여기강해산물재해색보조건하능구유효분리，검측한위2ng。결론：본방법간편、쾌속、령민、준학，가용우측정염산탁완사경중적유관물질。
Objective: To establish a HPLC method for the determination of related substances in Tropisetron Hydrochloride. Method:The analysis was performed on a C18 column, usingmobile phase consisted of Phosphate buffer (to take potassium dihydro-gen phosphate 6.8g, add 500ml water to dissolve, add triethylamine 5ml, diluted with water to 1000ml, adjusted to pH 3.5 with phos-phoric acid)-acetonitrile ( 80:20 ) was used as the mobile phase. The detection wavelength was 284 nm. Results:Tropisetron Hydro-chloride and the degradation products could be effective separation, The limit of detection was 2ng. Conclusion:The method was sim-ple,quick, sensitive and accurate. Related substances in Tropisetron Hydrochloride for Injection can be determined by HPLC.