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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 a HPLC method for the simultaneous determination of scopolamine hydrobromide, atropine sulfate, ephedrine hydrochloride and pseudoephedrine hydrochloride in Zhichuanling Oral Liquid. Methods: The mobile phase consisted of Acetonitrile-sodium phosphate buffer (containing 0.07 mol·L-1 of 17.5 mmol·L-1 sodium dodecyl sulfate) with Agela Durashell RP-C18 column (4.6 mm × 250 mm, Sodium phosphate solution, adjusted to pH 6.0 with phosphoric acid (30:70), flow rate 0.9 mL · min-1, detection wavelength at 207 nm, column temperature 25 ℃. Results: Scopolamine hydrobromide, atropine sulfate, ephedrine hydrochloride and pseudoephedrine hydrochloride showed good linearity in the ranges of 0.021 21 ~ 1.060 5,0.011 14 ~ 0.557,0.200 56 ~ 10.028,0.070 33 ~ 3.516 5μg and peak area, respectively 0.999 3,0.999 6,0.999 7,0.9996. The average recoveries (n = 6) were 101.9%, 99.80%, 100.3% and 100.2%, respectively. Conclusion: The method is rapid, simple, reproducible and specific. It can be used as one of the quality control methods for Zhichuanling Oral Liquid.