反相离子对高效液相色谱法同时测定非索伪麻缓释片中两组分含量  

Simultaneous Determination of Fexofenadine and Pseudoephedrine Sustained-Release Tablets by Reversed Phase Ion-Pair HPLC

作　　者：李颖[1] 

机构地区：[1]安徽省中医院,安徽合肥230031

出　　处：《中国药业》2010年第1期18-19,共2页China Pharmaceuticals

摘　　要：目的建立同时测定非索伪麻缓释片中两组分含量的反相离子对高效液相色谱法。方法采用Shim-packVP-ODS柱(150mm×4.6mm,5μm),以甲醇-0.05mol/L磷酸二氢钾-十二烷基硫酸钠(70∶30∶0.03,用磷酸调pH至3.0)为流动相,检测波长210nm,柱温30℃,流速1.0mL/min。结果盐酸非索非那定质量浓度在6.01～120.20mg/L范围内与峰面积线性关系良好,r=0.9999,平均回收率为99.82%,RSD=0.20%(n=9);盐酸伪麻黄碱质量浓度在12.08～241.68mg/L范围内与峰面积线性关系良好,r=0.9999,平均回收率为99.88%,RSD=0.29%(n=9)。结论反相离子对高效液相色谱法可对盐酸非索非那定和盐酸伪麻黄碱同时进行测定,具有快速、简便、灵敏、准确的特点。Objective To establish a reversed phase ion- pair HPLC method for simultaneously determining fexofenadine hydrochloride and pseudoephedrine hydrochloride in their sustained release tablet. Methods The Shim-pack VP- ODS column（150 mm × 4. 6 mm, 5 μm） was used with methanol-0.05 mol/L KH2PO4-SDS（70 ： 30：0.03, adjusted to pH 3.0 with phosphoric acid） as the mobile phase, the flow rate was 1.0 mL/min and the detection wavelength was 210 nm. The column temperature was 30℃. Results The good linearity range and recovery rate for fexofenadine hydrochloride was 6.01 - 120.20 mg/L, r = 0. 999 9, and 99.82%, RSD = 0.20% （ n = 9） respectively; while those for pseudoephedrine hydrochloride was 12.08 - 241.68 mg/L, r = 0. 999 9, and 99.88%, RSD = 0. 29% （ n = 9） respectively. Conclusion The method is simple, rapid, accurate and reliable.

关 键 词：反相离子对高效液相色谱法 盐酸非索非那定 盐酸伪麻黄碱 含量测定 

分 类 号：R927.2[医药卫生—药学] R976