hplc法测定罗红霉素片的溶出度 - 中国药品标准杂志.pdfVIP

2009 10 5 384 D rug Standards o f C hina 2009, V ol110 N o15 , , 316 , , , , 314 , , , ( 1 h) , , , [ 1] 1[ S] 12005 315 , , 420-42 11 [ 2] 1 [ J] 1 , , 2008, 9( 4) 2531 HPLC 钱锋( , 353000) 研究罗红霉素片的溶出介质, 建立了新的高效液相色谱法测定罗红霉素片的溶出度 以醋酸 缓冲液( pH 51 5) 为溶出介质, 转蓝法, 转速为 100 r# m in- 1, 45 m in 时取样, 取样后采用 HPLC 法测定 罗红霉素在 01 02 ~ 01 2 g# L- 1的范围内呈较好的线性关系 ( r = 01999 9) , 平均回收率为 991 6% ( R SD = 01 8% ) , 溶出液稳定, 片剂 17批在 45 m in 时平均 溶出度均在 80% 以上并且有较好的均 一性 方法快速简便, 结果准确可靠, 重现性好 罗红霉素片; 溶出度; 高效液相色谱法 92112 A 1009 - 3656 ( 2009) - 5 - 3 84 - 3 Development ofD issolutionM ethod ofRoxithromycin Ta lets yHPLC Q ian F eng(N anp ing Institutef or D rug con tro,l N anp ing 353000) A stract O jective To stu dy d isso lution m edium of R ox ithrom yc in T ab lets and deve lop a new disso lu tion m ethod by HPLC. M eth- ods The disso lution m ed ium w as aceta te buffer ( pH 5. 5 ) . A ppa ratu s 1 w as u sed w ith 100 r# m in- 1. T he dissolution m ed ium w as taken and analyzed by H PLC w hen 4 5 m inutes. R esults T he standard curve w as linea r in the range o f 0. 02 ~ 01 2 g# L- 1 ( r = 01 999 9) . The average recovery w as 99. 6% ( RSD = 0. 8% ) . The disso lu tion s o f 17 produc ts from d ifferent facto ries w ere over 80% . Con- clusion T he m ethod is smi ple and rap id. T he results are accurate and reprodu cib le. K ey words R ox ithrom yc in T ab lets; disso lu tion; H PLC , 1 [ 1] 56 2005 ,