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作 者:刘淑华
机构地区:[1]辽宁省朝阳市药品检验所,辽宁朝阳122000
出 处:《中国药业》2013年第13期31-32,共2页China Pharmaceuticals
摘 要:目的建立测定尼美舒利胶囊含量的反相高效液相色谱法。方法色谱柱为Kromasil C18柱(150 mm×4.6 mm,5μm),流动相为0.1%磷酸(用氨水调解pH至7.0)-乙腈(56∶44),柱温为室温,流速为1.0 mL/min,检测波长为403 nm,进样量为10μL。结果尼美舒利的线性范围为0.047 4~0.711 0μg(r=0.999 9,n=5),尼美舒利胶囊的高、中、低3种质量浓度的平均加样回收率为99.27%,RSD=0.80%(n=6)。结论该方法灵敏、准确、专属性强、重现性好,可用于尼美舒利胶囊含量的测定。Objective To establish a method for the content determination of Nimesulide Capsules by RP-HPLC.Methods The determination was performed on the Kromasil C18 column(150 mm×4.6 mm,5 μm) with 0.1%phosphoric acid(adjusted to pH=7.0 with ammonia solution)-acetonitrile(56 ∶44) as the mobile phase at the ambient temperature.The flow rate was 1.0 mL/min,the detective wavelength was 403 nm and the injection volume was 10 μL.Results The linear range of nimesulide was 0.047 4-0.711 0 μg(r=0.999 9,n=5).The average recovery rate for the high,middle and low concentrations of nimesulide was 99.27%(RSD=0.80%,n=6).Conclusion This method is sensitive,accurate,strongly specific and better reproducible,and can be used for the content determination of Nimesulide Capsules.
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