摘要
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.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第28期2219-2221,共3页
China Pharmacy