HPLC法测定克拉霉素胶囊的溶出度  

Determination of the dissolution rate for Clarithromycin Capsules by HPLC

作　　者：齐晓飞[1] 潘智鹏[2] 刘亚威[1] 姚兰[1] 王洋[1] 

机构地区：[1]辽宁省食品药品检验所,辽宁沈阳110023 [2]辽宁省肿瘤医院,辽宁沈阳110042

出　　处：《西北药学杂志》2011年第5期365-367,共3页Northwest Pharmaceutical Journal

摘　　要：目的建立高效液相色谱法测定克拉霉素胶囊的溶出度。方法照《中国药典》2005年版（二部）溶出度测定第二法，以醋酸盐缓冲液（pH5．0）900mL为溶出介质，转速为50r·min^-1，30min时取样。以高效液相色谱法，采用C18色谱柱（300mm×3．9mm，10μm）为固定相，以甲醇-0．067mol·L^-1磷酸二氢钾缓冲溶液（650：350）（用磷酸调节pH值至4．O）为流动相；检测波长为210nm，流速为1．5mL·min^-1，柱温为50℃。结果克拉霉素胶囊的线性范围为1．0491～3．9556μg（r=0．9999）；克拉霉素胶囊平均回收率为99．6％（RSD0．38％，n=12）。结论该方法简便，快速，准确，可用于其质量控制。Objective To establish an HPLC method for the determination of Clarithromycin Capsules dissolution rate. Method According to Appendix X C II of Chinese Pharmacopoeia 2005 edition Vol. U ,dissolution medium was 900 mL of 0.1mol · L^-1 sodium acetate solution and rotating speed was 50 r· min^-1. After 30 min,the dissolution solutions were taken and analyzed by HPLC method. A C18 column （300 mm × 3.9 mm,10 μm} was used with a mobile phase consisted of a mixture of methanol-mon- obasic potassium phosphate （adjust to pH 4.0 with phosphoric acid）（650 ： 350）. The wavelength used for detection was 254 nm; the column temperature was 50 ℃. The flow rate was about 1.5 mL · min^-1. Results Clarithromycin was linear over the range of 1. 049 1-3. 955 6 μg （ r =0. 999 9）;The recoveries was 99.6% （RSD=0.38%, n =12）. Conclusion The method was simple, convenient,rapid and accurate. It can be used as a method of quality control.

关 键 词：高效液相色谱法 紫外分光光度法 克拉霉素胶囊 溶出度 

分 类 号：R94[医药卫生—药剂学]