高效液相色谱法测定稳心颗粒中非法添加药物的含量  

HPLC Determination of Propranolol Hydrochloride,Verapamil Hydrochloride and Propafenone Hydrochloride Ilegally Mixed into Wenxin Granules

作　　者：张士勇[1] 程军[1] 叶云[1] 

机构地区：[1]安徽省蚌埠市第三人民医院药事办,安徽蚌埠233000

出　　处：《中国药业》2012年第6期36-37,共2页China Pharmaceuticals

摘　　要：目的建立检测稳心颗粒中非法添加的盐酸普萘洛尔、盐酸维拉帕米和盐酸普罗帕酮含量的高效液相色谱法。方法采用InertsilODS-SP C18色谱柱(250 mm×4.6 mm,5μm),流动相为磷酸盐缓冲液(取磷酸二氢钾6.8 g,辛烷磺酸钠1.3 g,加水溶解并稀释至1 000 mL,用磷酸调节pH至3.0)-甲醇(40∶60),流速为0.8 mL/min,检测波长为223 nm,柱温为25℃。结果盐酸普萘洛尔、盐酸维拉帕米和盐酸普罗帕酮进样量的线性范围分别为0.019 76～2.47μg(r=1),0.01～2.5μg(r=1)和0.009 948～2.487μg(r=1);平均回收率分别为97.11%,97.63%和98.88%,RSD分别为1.85%,1.92%和1.46%(n=6)。结论该方法准确、重现性好,可作为稳心颗粒中非法添加盐酸普萘洛尔、盐酸维拉帕米和盐酸普罗帕酮的有效检测方法。Objective To set up a method for the determination of propranolole hydrochloride, verapamil hydrochloride and propafenone hydrochloride illegally mixed into Wenxin Granules by HPLC. Methods The HPLC method was used. The Inertsil ODS- SP C18 column （250 mm ×4. 6 mm, 5 μm） was used with the mobile phase of phosphate buffer （adding water to dissolve potassium dihydrogen phosphate 6.8 g and sodium 1- octanesulfonate 1.3 g, and diluting to 1 000 mL, adjusting pH value to 3.0 with phosphoric acid ）- methanol（40：60）. The flow rate was 0. 8 mL/min, the detection wavelength was set at 223 nm and the column temperature was 25 ℃. Results The calibration curve showed the good linearity for propranolole hydrochloride, verapamil hydrochloride and propafenone hy- droehloride in the range of 00. 019 76 -2.47 μg（ r = 1） ,0.01 -2. 5 μg（ r = 1） and 0. 009 948 -2. 487μg（ r = 1） ,respectively;the average recovery rates （n =6） were 97. 11%, 97.63% and 98.88% , respectively; RSD were 1.85% , 1.92% and 1.46%, respectively. Conclusion This method is accurate and reproducible, which can be used for the determination of propranolole hydrochloride, verapamil hydroehloride and propafenone hydrochloride illegally mixed into Wenxin Granules.

关 键 词：高效液相色谱法 稳心颗粒 盐酸普萘洛尔 盐酸维拉帕米 盐酸普罗帕酮 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]