反相高效液相色谱法测定洛伐他汀胶囊的含量和有关物质  

Determination of Lovastatin and Related Substances in Lovastatin Capsules by RP-HPLC

作　　者：刘放[1] 

机构地区：[1]浙江省医学科学院药物研究所,浙江杭州310013

出　　处：《中国药业》2013年第19期48-50,共3页China Pharmaceuticals

基　　金：浙江省科技计划项目;项目编号:2011F10048;浙江省医学重点学科群项目;项目编号:XKQ-010-001

摘　　要：目的建立测定洛伐他汀胶囊含量及有关物质的反相高效液相色谱法。方法采用HypersilC18柱（250mm×4．6mm，10μm），以乙腈一磷酸盐缓冲液（pH=4．0）-甲醇（5：3：1）为流动相，检测波长为238nm。结果洛伐他汀质量浓度在80．63～322．53μg／mL范围与峰面积呈良好线性关系（r=0．9997，n=7），规格为10mg和20mg洛伐他汀的平均回收率分别为99．56％和99．67％，RSD分别为0．42％和0．83％（n=9）。洛伐他汀及其有关物质得到基线分离，方法的最低检测量为0．2ng，控制总杂质量不得超过2．0％。结论该法测定洛伐他汀胶裳的含量及有关物质，方法简便、快速、结果准确，专属性好，适用于洛伐他汀胶囊及其制剂的质量控制。Objective To establish a reversed phase high-performance liquid chromatography（RP-HPLC） method for the content de- termination of lovastatin and its related substances in Lovastatin Capsules. Methods The RP - HPLC method was developed. The determi- nation was performed on Hypersil C18 column（250 mm ×4.6 mm, 5 μm） with mobile phase of acetonitrile-phosphate buffer （pH =4.0） -methanol（5：3 ： 1）. The UV detection wavelength was set up at 238 nm. Results The linearity of lovastatin was good in the range of 80. 63 -322. 53 μg/mL（ r =0. 999 7, n =7）. The recovery rates of lovastatin were 99.56% for the specification of 10mg and 99.67% for the specification of 20 mg, RSD was 0. 42% （ n = 9） and 0.83% （ n = 9）. Lovastatin and its related substances were separated at the base line. The lowest detection amount was 0. 2 ng. The controlled total impurity amount did not exceed 2.0%. Conclusion This method is simple it is rapid with accurate detection results and good specificity. It is suitable for the quality control of Lovastatin Capsules and its preparations.

关 键 词：洛伐他汀 洛伐他汀胶囊 有关物质 质量控制 反相高效液相色谱法 

分 类 号：R927[医药卫生—药学] R972.6