CAJ | 학술논문

目的：建立了RP-HPLC法测定注射用盐酸阿柔比星的含量并进行有关物质检查。方法：采用Agilent Eclipse XDB-C18色谱柱；流动相为乙二胺四乙酸二钠缓冲溶液[取乙二胺四乙酸二钠二水合物1.86g，加水900mL溶解，加三乙胺2.5mL，用冰醋酸调节pH至4.0，再加水至1000mL]-乙腈（63：37）；流速：1.0mL·min-1；检测波长：432nm；柱温：25℃。结果：盐酸阿柔比星在1.00μg·mL-1～400.00μg·mL-1范围内线性关系良好（r=0.9999），平均回收率为99.68%（ RSD=0.54%），盐酸阿柔比星与有关物质得到良好的分离，检测限为5.18ng,定量限为20.62ng。结论：该方法简便、快速、准确，重复性好，专属性强，可用于盐酸阿柔比星的含量测定和有关物质的检查。
목적：건립료RP-HPLC법측정주사용염산아유비성적함량병진행유관물질검사。방법：채용Agilent Eclipse XDB-C18색보주；류동상위을이알사을산이납완충용액[취을이알사을산이납이수합물1.86g，가수900mL용해，가삼을알2.5mL，용빙작산조절pH지4.0，재가수지1000mL]-을정（63：37）；류속：1.0mL·min-1；검측파장：432nm；주온：25℃。결과：염산아유비성재1.00μg·mL-1～400.00μg·mL-1범위내선성관계량호（r=0.9999），평균회수솔위99.68%（ RSD=0.54%），염산아유비성여유관물질득도량호적분리，검측한위5.18ng,정량한위20.62ng。결론：해방법간편、쾌속、준학，중복성호，전속성강，가용우염산아유비성적함량측정화유관물질적검사。
Objective:To establish a RP-HPLC method for determining the contents of aclarubicin hydrochloride for injection and its related substances. Agilent Eclipse XDB-C18 was adopted with disodium edentate buffer solution[dissolved 1.86 g disodium edentate in 900mL water, added 2.5mL triethylamine and adjusted to pH 4.0 with acetic acid,then added water to 1000mL]-acetoni-trile (63:37) as the mobile phase.The flow rate was 1 mL·min-1 , the wavelength was set at 432nm and the column temperature at 25℃. The linearity of aclarubicin hydrochloride for injection was in the range of 1.00 to 400.00μg·mL-1(r=0.9999).The average recovery was 99.68%(RSD=0.54%).The related substances of aclarubicin hydrochloride were completely separated from aclarubicin hydro-chloride .The limit of determination was 5.18ng and the limit of quantification was 20.62ng. The method is proven to be simple,rapid, accurate, reproducible and specific ,and is suitable for the determination of aclarubicin hydrochloride and its related substances.