摘要
目的:研究罗红霉素片的溶出介质,建立了新的高效液相色谱法测定罗红霉素片的溶出度。方法:以醋酸盐缓冲液(pH5.5)为溶出介质,转蓝法,转速为100r.min-1,45min时取样,取样后采用HPLC法测定。结果:罗红霉素在0.02～0.2g.L-1的范围内呈较好的线性关系(r=0.9999),平均回收率为99.6%(RSD=0.8%),溶出液稳定,片剂17批在45min时平均溶出度均在80%以上并且有较好的均一性。结论:方法快速、简便,结果准确可靠,重现性好。
Objective：To study dissolution medium of Roxithromycin Tablets and develop a new dissolution method by HPLC. Methods：Tbe dissolution medium was acetate buffer （pH 5.5）. Apparatus 1 was used with 100 r · min ^-1. The dissolution medium was taken and analyzed by HPLC when 45 minutes. Results：The standard curve was linear in the range of 0. 02 -0. 2 g · L^-1 （r =0. 999 9）. The average recovery was 99.6% （RSD =0.8% ）. The dissolutions of 17 products from different factories were over 80%. Conclusion ：The method is simple and rapid. The results are accurate and reproducible.
出处
《中国药品标准》
CAS
2009年第5期384-386,共3页
Drug Standards of China
