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目的:建立咳特灵胶囊中马来酸氯苯那敏和芦丁的含量测定方法。方法:应用高效液相色谱法测定,色谱柱为Agilent Zorbax SB-C18色谱柱(4.6mm×150mm,5μm);流动相为甲醇-0.1%磷酸,梯度洗脱;流速为1.0mL·min-1,柱温30℃;检测波长270nm。结果:马来酸氯苯那敏和芦丁的线性范围分别为0.02268～0.3627mg·mL-1(r=0.9999),0.6644～132.9μg·mL-1(r=1.0000);平均加样回收率分别为100.19%(RSD=1.70%),99.90%(RSD=1.35%)。结论:该方法简便易行、准确、重复性好,可用于咳特灵胶囊的质量控制。
Objective: To establish a method for the determination of chlorphenamine maleate and rutin in Keteling capsules. Methods: The HPLC was performed on an Agilent Zorbax SB-C18 column (4.6 mm × 150 mm, 5 μm) using a mobile phase of methanol-0.1% phosphoric acid with gradient elution at a flow rate of 1.0 mL · min -1 , Column temperature 30 ℃; detection wavelength 270nm. Results: The linear ranges of chlorpheniramine maleate and rutin were 0.02268 ~ 0.3627 mg · mL -1 (r = 0.9999) and 0.6644 ~ 132.9 μg · mL -1 (r = 1.0000) respectively. The average recoveries of chlorphenamine maleate and rutin were 100.19% (RSD = 1.70%), 99.90% (RSD = 1.35%). Conclusion: The method is simple, accurate, reproducible and can be used for the quality control of Keteling capsules.