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.
出处
《中国药业》
CAS
2012年第6期36-37,共2页
China Pharmaceuticals
