摘要
目的:建立左炔诺孕酮片溶出度测定方法,为评价和控制药品质量提供依据。方法:以0.1mol/L盐酸溶液(含0.1%SDS)1000mL为溶出介质,转速75转/min,取样时间30min。用高效液相色谱法测定,色谱柱为Diamonsil C18柱(4.6mm×150mm,5μm);流动相为乙腈-水(70∶30);流速为1.0mL/min;检测波长为242nm;柱温为25℃。结果:方法线性范围为0.312～1.873μg/mL,r=1;平均回收率为100.6%,RSD为0.67%(n=12)。测定不同批次左炔诺孕酮片溶出度,均大于85%。结论:方法具有灵敏、准确、快速的优点,适用于左炔诺孕酮片的质量控制。
Objective To develop a method for dissolution test of Levonorgestrel Tablets.Methods Dissolution method was used,with1000 mL 0.1% solution of sodium dodecyl sulfate in hydrochloride solution(0.1 mol·L-1)as elute phase at 75 rpm specified for 30 minutes.The column was Diamonsil C18 column(4.6 mm×150 mm,5μm),the mobile phase consisted of acetonitrile-water(70∶30)with a flow rate of 1.0 mL·min-1.The column temperature was set at 25℃,and the detection wavelength was 242 nm.Results The average recovery was100.6% with RSD of 0.67%(n=12),it had a good linearity in the concentration range of 0.312~1.873μg·mL-1(r=1).The percentage of dissolution of Levonorgestrel Tablets in 30 minutes was more than 85%.Conclusion The method was accurate and reproducible,and can be used for the determination of Levonorgestrel Tablets.
作者
金滨滨
姜良银
张敬富
石俊伟
Jin Binbin;Jiang Liangyin;Zhang Jingfu;Shi Junwei(Shandong Xinhui Pharmaceutical Co.,Ltd,Linyi 276023,China)
出处
《北方药学》
2019年第1期3-5,共3页
Journal of North Pharmacy
