HPLC法测定洛伐他汀烟酸缓释片中烟酸的含量

目的:建立测定洛伐他汀烟酸缓释片中烟酸含量的方法。方法:采用高效液相色谱法。色谱柱为ZorbaxC8柱,流动相为乙腈-甲醇-0.01mol.L-1己烷磺酸钠-冰醋酸(4:6:89:1),流速为1.0mL.min-1,检测波长为263nm,柱温为25℃,进样量为20μL。结果:烟酸检测浓度在20.12～100.6μg.mL-1范围内与峰面积积分值呈良好的线性关系(r=0.9999);平均加样回收率为99.71%,RSD=0.43%(n=9)。结论:本方法操作简便、结果准确,可用于该制剂中烟酸的定量分析及制剂质量控制。

Content Determination of Niacin in Niacin Lovastatin Sustained-release Tablets by HPLC

OBJECTIVE：To establish a method for the content determination of niacin in Niacin lovastatin sustained-release tablets.METHODS：HPLC method was adopted.The determination was performed on Zorbax C8 column with mobile phase consisted of acetonitrile-methanol-0.01 mol·L-1 hexane sulfonic acid sodium-glacial acetic acid（4：6：89：1） at the flow rate of 1.0 mL·min-1.The detection wavelength was set at 263 nm,and the column temperature was 25 ℃.The injection volume was 20 μL.RESULTS：The niacin had a good linearity in the rang of 20.12～100.6 μg·mL-1（r=0.999 9） with an average recovery of 99.71%（RSD=0.43%,n=9）.CONCLUSION：The established method is simple and accuracy.It can be applied for quality control of niacin in Niacin lovastatin sustained-release tablets.