洛伐他汀片溶出度测定

Determination of the Dissolution of Lovastatin Tablets

目的:建立测定洛伐他汀片剂溶出度的方法,并以此考察不同厂家洛伐他汀片剂的溶出度。方法:含量测定方法为高效液相色谱法,色谱柱为AlltimaC18,流动相为乙腈-0.01%磷酸(60∶40),检测波长为238nm;溶出度测定方法采用桨法,以2%十二烷基硫酸钠-磷酸盐缓冲溶液(pH7.0)为溶出介质,转速为50r.min-1,取样时间为30min。对6个厂家12批样品进行了溶出度测定。结果:洛伐他汀检测浓度线性范围为4.88～195.2μg.mL-1(r=0.9999),平均回收率为97.7%(RSD=1.3%,n=9);12批样品中有2个厂家3批样品平均溶出量在80%以下,其余均为80%～101%。结论:本方法准确、重现性好、操作简单,能有效控制产品质量。

OBJECTIVE： To establish a method for determination of the dissolution of lovastatin tablets and to investigate the dissolution of it from different manufactures. METHODS： HPLC was employed for content determination with Alltima C18 chromatographic column, and the mobile phase consisted of acetonitrile- 0.01% phosphoric acid （60 ： 40） with the detective wavelength set at 238 nm. The dissolution was determined by paddle method with 2% sodium lauryl sulphate- phosphate buffered solution （pH 7.0） as medium at a rotation speed of 50 r ·min -1, and the sampling time was 30 rain. The dissolution rates of 12 batches of samples from 6 manufacturers were determined. RESULTS： The linear range of lovastatin was 4.88-- 195.2μg·mL^-1（r = 0.999 9） and its average recovery rate was 97.7% （RSD = 1.3%, n = 9）. Of the 12 batches of samples, 3 batches from 2 manufacturers had dissolution rates of less than 80% , and the other batches stood at 80%- 101%. CONCLUSION： The method is accurate, reproducible and simple, and it is effective in the quality control of lovastatin tablets.