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[摘要]
目的 建立山楂红曲胶囊中洛伐他汀的处理及含量测定方法。方法 色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),紫外检测波长238 nm,柱温25℃,体积流量1.0 mL/min,流动相为甲醇:0.1%磷酸溶液(75:25)。结果 洛伐他汀质量浓度在2.04~306 μg/mL与峰面积线性关系良好,平均回收率为98.58%,RSD=1.12%(n=9)。结论 该方法准确、简便,可用于山楂红曲胶囊的质量控制。
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[Abstract]
Objective To establish a method of processing and determining for the lovastatin in Monascus Capsules.Methods Inspecting the influence of water bath temperature to the transformation of lovastatin structure,on the basis of "content determination standards for lovastatin in the health food".Chromatographic separation was achieved on a Kromasil C18 analytical column (250 mm×4.6 mm,5 μm),and the detection wavelength was set at 238 nm,maintained at 25℃.The prepared mobile phase was delivered at a flow rate of 1.0 mL/min.The mobile phase consisted of 75% Methano and 25% Phosphoric acid (0.1%).Results the linear range was 2.04 to 306 μg/mL.The average recovery was 98.58%.The precision was 1.12%(n=9).Conclusion The improved method for determination is that transforming acid structure of lovastatin into lactone structure,the method which is accurate and simple can be applied to control the quality of Monascus Capsules.
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