高效液相色谱法测定旨益胶囊中洛伐他汀的含量

Determination of Lovastatin Content in Zhiyi Capsules by HPLC

目的:用高效液相色谱法测定旨益胶囊中洛伐他汀的含量。方法:C_(18)色谱柱(250mm×4.6mm,5μm),以甲醇-水-磷酸(385:115:0.14)为流动相,检测波长为238 nm,流速为1mL/min。结果:线性关系r=0.9990,表明在浓度为2.0μg/mL～300μg/mL范围内,峰面积积分值与浓度呈良好的线性关系,平均回收率为95.68%,RSD为0.85%,洛伐他汀含量限度为135.8mg/100g。结论:HPLC法专属性强,灵敏度高,含量测定方法准确可靠,适用于该产品的质量检测。

Objective:HPLC method was used to detect the content of lovastatin in Zhiyi Capsules.Methods:C_(18) chromatographic column(250mm×4.6mm,5μm)was used,the mobile phase was consisted of Methanol-water-phosphoric acid (385:115:0.14)with UV detection wavelength at 238nm,flow rate is 1mL/min.Results:The calibration curve was in good linearity between the score of peak area and concentration over the range of 2.0μg/mL～300μg/mL(r=0.9990),the average recovery was 95.68%,RSD was 0.85%,the content limitation of lovastatin was 135.8mg,/100g.Conclusion:HPLC method possessed strong specificity and high sensitivity,and the method is accurate and reliable to detect the content and is suitable to control the quality of Zhiyi Capsules.