HPLC法同时测定美愈伪麻胶囊中三个组分的含量

Simultanenous determination of the contents of the three components in guaifenesin,pseudoephedrine hydrochloride and dextromethorphan hydrobromide capsules by HPLC

目的用HPLC法测定美愈伪麻胶囊中盐酸伪麻黄碱 (Ⅰ )、愈创木酚甘油醚 (Ⅱ )、氢溴酸右美沙芬 (Ⅲ )的含量。方法以非那西汀为内标物 ,色谱柱为DiamonsilODS (4 .6mm× 2. 0 0 0mm ,5 μm) ,以 0. 0 3mol·L-1NaH2 PO4溶液 (用H3 PO4调节 pH值至 3. 0 ) 甲醇 乙腈 (V∶V∶V =6 0∶35∶5 )为流动相 ,检测波长 2 0 7nm。结果组分Ⅰ在 6 .2～ 4. 3 1mg·L-1(r =0 .9993) ,组分Ⅱ在 2 0 . 0～ 14 0 . 0mg·L-1(r =0 . 9990 ) ,组分Ⅲ在 2. 0～ 14 . 0mg·L-1(r =0 9999)内呈良好的线性关系 ,平均回收率分别为 99. 7% (RSD =0 . 4 % )、10 0 . 0 % (RSD =0 . 4 % )、10 0 . 2 % (RSD =1. 0 % )。结论可用于美愈伪麻胶囊的质量控制。

Objective To establish a HPLC method for the determination of pseudoephedrine hydrochloride(Ⅰ),guaifenesin(Ⅱ) and dextromethorphan hydrobromide(Ⅲ) in the guaifenesin pseudoephedrine hydrochloride and dextromethorphan hydrobromide capsules.Methods The Diamonsil ODS column was used with a mobile phase of 0.03 mol·L~ -1 NaH 2PO 4 aqueous solution (adjusted to pH 3.0 with H 3PO 4)-methanol-acetonitrile (V∶V∶V=60∶35∶5).The UV detective wavelength was set at 207 nm.Results Phenacetin was used as the internal standard compound.The calibration curves were linear throughout the range of 6.2～43.1 mg·L~ -1(r= 0.999 3) for componentⅠ,20.0～140.0 mg·L~ -1( r= 0.999 0) for component Ⅱ and 2.0～14.0 mg·L~ -1( r= 0.999 9)for component Ⅲ,respectively.The average recoveries were 99.7%(RSD=0.4%),100.0%(RSD=0.4%) and 100.2%(RSD=1.0%),respectively.Conclusions The method is reliable for the quality control of guaifenesin,pseudoephedrine hydrochloride and dextromethorphan hydrobromide capsules.