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机构地区:[1]温州医学院附属第二医院药剂科,浙江温州325027
出 处:《中国药业》2011年第18期31-32,共2页China Pharmaceuticals
摘 要:目的建立测定厄多司坦胶囊含量的反相高效液相色谱法。方法采用Hypersil ODS柱(250 mm×4.6 mm,5μm),以pH=6.8的磷酸缓冲溶液-甲醇(95∶5)为流动相,流速1.0 mL/min,检测波长为237 nm,柱温为室温。以外标法峰面积定量。结果在该色谱条件下,厄多司坦质量浓度在1~50μg/mL范围内与峰面积线性关系良好,r=0.999 7,平均回收率为99.13%,RSD为0.84%(n=6),重复性试验的RSD为0.92%(n=6)。结论所用方法简便、可靠、准确,可用于厄多司坦胶囊的质量控制。Objective To establish a RP-HPLC method for the determination of the content Erdosteine Capsules.Methods The chromatographic column was a Hypersil ODS column(250 mm ×4.6 mm,5 μm),the mobile phase was composed of pH=6.8 Phosphoric acid buffer solution-methanol(95 ∶5),the flow rate was 1.0 mL/min,the detection wavelength was 237 nm and column temperature was room temperature.Results The linear range of erdosteine was 1-50 μg/mL(r=0.999 7).The average recovery was 99.13%with RSD=0.84%(n=6).RSD of repeatability was 0.92%(n=6).Conclusion This method is simple,reliable and accurat,it can be used for quality control of erdosteine capsules.
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