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机构地区:[1]浙江省宁波市药品检验所,宁波315040 [2]中国药品生物制品检定所,北京100050
出 处:《药物分析杂志》2006年第1期132-133,共2页Chinese Journal of Pharmaceutical Analysis
摘 要:目的:建立 HPLC 法测定小儿化痰止咳冲剂中盐酸麻黄碱含量。方法:采用岛津 Shim-pack C_(18)(4.6mm×150mm,5μm)色谱柱,流动相为乙腈-0.1%磷酸(1:9),流速为1.0mL·min^(-1),检测波长为207nm。结果:盐酸麻黄碱线性范围为30.34~303.4ng;精密度试验 RSD 为0.3%,重复性试验 RSD 为0.3%,平均回收率为100.4%,RSD=0.8%(n=6)。结论:该方法简便、可靠、准确,可用于该制剂的质量控制。Objective: To establish a method of HPLC for determination of ephedrine hydrochloride in Xiao'er Zhike Huatan Chongji. Methods:A Shim -pack C18 (4.6 mmx 150 mm,5 μm)column was used. Acetonitrile -0. 1% phosphoric acid(1:9) was used as the mobile phase. The flow rate was 1.0 mL ·min^-1. The detection wavelength was 207 nm. Results: The linear range was 30. 34 - 303.4 ng. The precisions (RSD) was 0.3 %. The reproducibility (RSD) of this method was 0.3%. The average recovery rate was 100.4%, with RSD = 0. 8% (n = 6 ). Conclusion: The method is simple, reliable, accurate and can be applied to the quality control of the preparation.
分 类 号:R917[医药卫生—药物分析学]
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