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[摘要]
目的 建立同时测定对乙酰氨基酚、马来酸氯苯那敏、绿原酸、牛蒡苷含量的方法,旨在实现准确、高效、实用地控制维C银翘片的质量。方法 采用HPLC波长切换方法,色谱柱为DIONEX Acclaim C18 (250 mm×4.6 mm,5 μm,Dionex Bonded Silica Products),流动相为乙腈-含0.5%三乙胺的0.02 mol/L磷酸二氢钾(pH2.5)水溶液,梯度洗脱,体积流量为1.0 mL/min,柱温30℃,检测波长249 nm(0~10 min,检测对乙酰氨基酚)、327 nm(10~20 min,检测绿原酸)、264 nm(20~32 min,检测马来酸氯苯那敏)、280 nm(32~44 min,检测牛蒡苷)。结果 对乙酰氨基酚、绿原酸、马来酸氯苯那敏、牛蒡苷分别在0.040~0.800、0.065~1.301、0.041~0.818、0.093~1.852 μg内与峰面积呈良好的线性关系(r>0.999),平均加样回收率(n=6)分别为99.7%(RSD=1.4%)、100.4%(RSD=1.2%)、100.5%(RSD=1.3%)、99.4%(RSD=1.5%)。对乙酰氨基酚、绿原酸、牛蒡苷采用2种方法测定,经t检验结果无显著性差异;马来酸氯苯那敏采用本文建立的方法测定,含量略高于药典方法。结论 本实验建立的含量测定方法与《中国药典》收载的方法比较,本方法检测结果可靠,且操作简单、环境友好、灵敏度高,符合方法学验证要求,可用于维C银翘片的质量控制。
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[Abstract]
Objective To establish a method for Simultaneous determination of four constituents (paracetamol; chlorpheniramine maleate; chlorogenicacid; arctiin), in order to control the quality of Vitamin C Yinqiao Tablets accurately,efficiently and practically. Methods In the HPLC with switching wavelength method, the separation was performed on a DIONEX Acclaim C18 (250 mm×4.6 mm, 5 μm, Dionex Bonded Silica Products) column with the gradient elution of acetonitrile-0.5% triethylamine 0.02 mol/L NaH2PO4 (pH2.5) solution in a gradient mode at the flow rate of 1.0 mL/min. The column temperature was set at 30℃. The UV detection wavelength was set at 249 nm for paracetamol in 0-10 min, 327 nm for chlorogenic acid in 10-20 min, 264 nm for chlorpheniramine maleate for 20-32 min, 280 nm for arctiin in 32-44 min. Results The ranges for linear correlation of paracetamol, chlorpheniramine maleate, chlorogenicacid, arctiin were 0.040-0.800, 0.065-1.301, 0.041-0.818, 0.093-1.852 μg. The average recoveries (n=6) of the four components were 99.7% (RSD=1.4%), 100.4% (RSD=1.2%), 100.5% (RSD=1.3%), 99.4% (RSD=1.5%). The t-test results of Paracetamol, Chlorogenicacid and arctiin by both method have no significant difference, while the result of Chlorpheniramine maleate by established method is slightly higher than the corresponding method in Chinese Pharmacopoeia.Conclusion Compared to the corresponding method in Chinese Pharmacopoeia, the established method is reliable and consistent with method validation requirements, which has the characteristic of easy maneuverability,environmental friendliness, high sensitivity, therefore can be used for the quality control of vitamin C Yinqiao tablets.
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