HPLC法测定注射用门冬氨酸阿奇霉素的含量和有关物质.PDFVIP

2005 6 30 6 347 : 1001-8689( 2005) 06-0347-03 HPLC 1 1, * 1 2 3 纪标　王东凯 　薛梅妍　李志强　徐飒 　　　　　　　　　　　　　　( 1 沈阳药科大学药学院,　沈阳110016; 2 沈阳双鼎制药有限公司;　沈阳110016; 3 沈阳沃森药物研究所,　沈阳110016) : HPLC Diamonsil C 18 ( 250mm4. 6mm , 10m) , 0. 1mol/ L ( H9.0) (5545) , 1. 2ml/ min, 210nm , 35 0. 52. 5mg/ ml , r = 0. 9997, 99. 52% , RSD 0. 65% ( n= 9) , : ; ; : R927. 2: A Determination of azithromycin aspartate for injection and its related substances by HPLC 1, - 1, - 1, - 2 3 Ji Biao Wang Dong kai Xue M ei yan Li Zhi qiang and Xu Sa ( 1 , 110016; De artment of Pharmaceutics of Shenyang Pharmaceutical University Shenyang 2 Shenyang Shuangding Pharmaceut ical Co . , Lt d. , Shenyang 110016; 3 Watson Pharmaceutical Inst itute of Shenyang, Shenyang 110016) ABSTRACTObjective T o establish an HPLC method for the determination of azithromycin and its related substances in azithromycin as artate for injection. M ethodsA C18 column ( Diamonsil, 250mm 4. 6 , 10 ) ; : 0. 1 / ( 9. 0) ( 5545) ; mm m w as used mobile hase mol L hos hate buffer H acetonitrile flow rate: 1. 2 ml/ min; w avelength: 210nm; the tem erature of column: 35 . Results T he linear range for azithromycin w as 0. 52. 5mg/ ml ( r= 0. 9997) . T he average recovery of 99. 52% w as obtained w ith a RSD of 0.