摘要
建立了那格列奈片的体外溶出度测定方法,以pH6.8磷酸缓冲液 500 mL为溶出介质,浆法,50 r/min;溶出度测定采用HPLC法。线性范围10～200μg/mL(r=0.999 8),方法的回收率为(100.2±0.514 8)％。建立的那格列奈片体外溶出度测定方法可较好控制该片质量。
To develop a method for dissolution determination of nateglinide tablets in vitro, the dissolution was determinedwith paddle method (50 r·min^1) in 500 mL pH6 .8 phosphate buffer. Nateglinide was detected by HPLC. The linear calibra-tion curves were obtained in concentration range of 10--200 μg/mL (r = 0 .9998); average recovery was 100.2±0.5％. Thequality of the tablets can be well controlled by this method.
出处
《科学技术与工程》
2003年第3期239-241,共3页
Science Technology and Engineering
基金
军事医学科学院基金(9805106)
