保健食品中洛伐他汀含量测定的研究

The Determination Content of Lovastatin in Health Food Research

目的:建立以红曲为原料的保健食品中洛伐他汀含量测定的方法。方法:用内酯式洛伐他汀的标准品碱化水解制备酸式洛伐他汀标准品,用高效液相色谱法测定红曲类保健食品中洛伐他汀的总含量,以0.1 mol/L NaOH为提取溶剂,50℃下超声提取试样,色谱条件为:色谱柱(Kromasil C18柱4.6 mm×250 mm,5μm);流动相︰乙腈/0.05%磷酸=75/25;检测波长:238 nm;流速:1.0 m L/min;柱温:室温;进样量:10μL。结果:酸式洛伐他汀在5.4~206.0μg/m L范围内呈现良好的线性关系(r=0.99999);本方法重现性试验相对标准偏差是0.44%(n=6),回收率范围97.4%~100.2%。结论:本高效液相色谱法简单、快速、准确地测定洛伐他汀的总含量。

Objective： To establish a method to determine the content of lovastatin contained in health food made with red yeast rice as raw material. Methods： With the standard of lovastatin lactone type alkaline hydrolysis preparation of lovastatin acid standard, total content by HPLC method for the determination of lovastatin in health food, 0.1mol/L NaOH as the extraction solvent, the temperature of 50 ℃ ultrasonic extraction samples, chromatographic condition： chromatographic column （Kromasil column C18 4.6 mm×250 mm, 5 μm）; mobile phase： acetonitrile/0.05 % phosphoric acid=75/25; detection wavelength： 238 nm; flow rate： 1 mL/min; column temperature： room temperaatre; injection volume： 10 μL. Results： Lovastatin acid in the 5.4-206.0 μg/mL range showed a good linear relationship （r=0.99999）; the method can test the relative standard deviation is 0.44 % （n=6）, the recovery ratewas 97.4 %-100.2 %. Conclusion： This HPLC method is simple, rapid and accurate determination of the total amount of lovastatin.