中国中药杂志

2013, v.38(19) 3291-3294

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HPLC同时测定止喘灵口服液中氢溴酸东莨菪碱、硫酸阿托品、盐酸麻黄碱和盐酸伪麻黄碱的含量
Simultaneous determination of scopolamine hydrobromide,atropine sulfate,ephedrine hydrochloride and pseudoephedrine hydrochloride in Zhichuanling oral liquid with HPLC

张妤琳;李玉萍;
ZHANG Yu-lin;LI Yu-ping;Jiangsu Institute for Drug and Food Control;Jiangsu SZYY Group Pharmaceutical Limited;

摘要(Abstract):

目的:建立同时测定止喘灵口服液中氢溴酸东莨菪碱、硫酸阿托品、盐酸麻黄碱和盐酸伪麻黄碱含量的高效液相色谱法。方法:采用Agela Durashell RP-C18色谱柱(4.6 mm×250 mm,5μm),流动相为乙腈-磷酸钠缓冲液(含17.5 mmol·L-1十二烷基硫酸钠的0.07 mol·L-1磷酸钠溶液,用磷酸调节pH 6.0)(30∶70),流速0.9 mL·min-1,检测波长207 nm,柱温25℃。结果:氢溴酸东莨菪碱、硫酸阿托品、盐酸麻黄碱和盐酸伪麻黄碱分别在0.021 21~1.060 5,0.011 14~0.557,0.200 56~10.028,0.070 33~3.516 5μg与峰面积呈良好的线性关系,r分别为0.999 3,0.999 6,0.999 7,0.9996;平均回收率(n=6)分别为101.9%,99.80%,100.3%,100.2%。结论:该方法快速简便,重复性好,专属性强,可作为止喘灵口服液的质量控制方法之一。
Objective: To establish an HPLC method for determining the contents of scopolamine hydrobromide,atropine sulfate,ephedrine hydrochloride and pseudoephedrine hydrochloride in Zhichuanling oral liquid. Method: Agela Durashell RP-C18( 4. 6mm × 250 mm,5 μm) was adopted,with acetonitrile-sodium phosphate buffer solution( 0. 07 mol·L- 1sodium phosphate solution with 17. 5 mmol·L- 1sodium dodecylsulfate adjusted to pH 6. 0 with phosphoric acid solution)( 30∶ 70) as the mobile phase. The flow rate was 0. 9 mL·min- 1,the detection wavelength was 207 nm,and the column temperature was 25 ℃. Result: Scopolamine hydrobromide,atropine sulfate,ephedrine hydrochloride and pseudoephedrine hydrochloride showed good linear relations with peak areas within the concentration range of 0. 021 21-1. 060 5 μg( r = 0. 999 3),0. 011 14-0. 557 μg( r = 0. 999 6),0. 200 56-10. 028 μg( r =0. 999 7) and 0. 070 33-3. 516 5 μg( r =0. 999 6),respectively,with the average recoveries of 101. 9%,99. 80%,100. 3%,100. 2%( n = 6). Conclusion: The method was so quick,simple,highly reproducible and specific that it could be used as one of quality control methods of Zhichuanling oral liquid.

关键词(KeyWords): 止喘灵口服液;氢溴酸东莨菪碱;硫酸阿托品;盐酸麻黄碱;盐酸伪麻黄碱
Zhichuanling oral liquid;scopolamine hydrobromide;atropine sulfate;ephedrine hydrochloride;pseudoephedrine hydrochloride

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作者(Author): 张妤琳;李玉萍;
ZHANG Yu-lin;LI Yu-ping;Jiangsu Institute for Drug and Food Control;Jiangsu SZYY Group Pharmaceutical Limited;

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