HPLC法测定头孢羟氨苄胶囊的溶出度  

Determination of the dissolution of Cefadroxil Capsules by HPLC

作　　者：孔令洋[1] 孙巧巧[1] 薛雯[1] 

机构地区：[1]济宁市药品检验所,山东济宁272100

出　　处：《药学研究》2013年第9期515-516,共2页Journal of Pharmaceutical Research

摘　　要：目的 建立头孢羟氨苄胶囊的溶出度测定方法.方法 采用十八烷基硅烷键合硅胶为填充剂,以0.05 mol·L-1磷酸二氢钾-乙腈（95∶ 5）为流动相,检测波长为230 nm;分别采用高效液相色谱法和药典规定的紫外自身对照法测定头孢羟氨苄胶囊的溶出度.结果 头孢羟氨苄高效液相色谱测定法在10～100 μg＆#183;mL-1呈线性（r=0.999 9,n=5）,回收率100.8%,RSD=0.4%,重复性试验RSD=0.09%;与紫外法相比更能反映样品溶出的真实情况,达到质量控制的目的 .结论 本方法准确,灵敏,重现性好,可行.Objective To establish the assay method of dissolution test on Cefadroxil Capsules. Methods A Phe- nomenex C18 column was used with the mobile phase of acetonitrile -0. 05 mol·L-l dihydropotassium phosphate（ 5：95）. The determination wavelength was 230 nm. The methods of HPLC and UV were compared. Results The cefadroxil was linear within the concentration range of 10 - 100 μg· mL- 1 （r = 0. 999 9, n = 6）. The average recovery was 100. 8% and RSD was 0. 4% , The RSD of accuracy experiment was 0. 09%. Conclusion The results showed that the method was accurate, reliable, recurrent well, and can be used for the quality control.

关 键 词：溶出度 头孢羟氨苄胶囊 紫外分光光度法 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]