HPLC法测定左旋泮托拉唑钠肠溶微丸的含量和有关物质  

Determination of content and related substances in (-)-pantoprazole sodium enteric-coated pellets by HPLC

作　　者：张春叶[1] 王东凯[1] 孔俐文[1] 高飞[1] 王庆河[2] 程卯生[2] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]沈阳药科大学制药工程学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2008年第7期576-580,共5页Journal of Shenyang Pharmaceutical University

摘　　要：目的测定左旋泮托拉唑钠肠溶微丸胶囊的含量和有关物质。方法建立HPLC法,色谱柱：DiamonsilTMC18（5μm,4.6 mm×250 mm）,流动相：乙腈-磷酸盐缓冲液（取磷酸氢二钠1.12 g,磷酸二氢钠0.18 g,加水溶解并稀释至1 000 mL,调pH值至7.6）（体积比为30∶70）,检测波长：288 nm。结果左旋泮托拉唑在20.0～100.0 mg·L^-1内线性关系良好,r=0.999 6,平均回收率为99.3%（n=9）,RSD%=0.54。结论方法可用于制剂的含量和有关物质测定。Objective To establish a method to determine the contents of（ - ）-pantoprazole sodium and related substances in（ - ）-pantoprazole Sodium enteric-coated pellet capsules. Methods An assay of（ - ）-pantoprazole sodium enteric-coated pellet capsules was performed by HPLC using an DiamonsilTM column（5 μm, 4.6 mm × 250 mm）. The mobile phase was 30 % volume of acetonitrile, 70 % volume of phosphate buffer salt（sodium hydrogen phosphate 1.12 g, sodium dihydrogen phosphate 0.18 g, add water to 1 000 mL, adjusted to pH 7.6） ; the detection wavelength was set at 288 nm. Results （ - ）-Pantoprazole sodium had a good linear relationship between 20.0 - 100.0μg·mL^-1 （ r = 0. 999 6）, and the average recovery was 99. 3 % （n = 9） with RSD% of 0.54. Conclusions The method is simple, accurate and can be used to determine the content and related substance of（ - ）-pantoprazole sodium enteric-coated pellet capsules.

关 键 词：高效液相色谱法 左旋泮托拉唑钠 含量测定 有关物质 

分 类 号：R943.4[医药卫生—药剂学]