摘要
目的:针对苯磺酸氨氯地平有显著降压效果,建立苯磺酸氨氯地平片的质量控制研究,为复方质量控制标准提供依据。方法:采用高效液相色谱(HPLC)法测定苯磺酸氨氯地平的含量。色谱柱:Phenomenex C18柱(200 mm×4.6 mm,5μm);流动相:0.03 mol.L-1KH2PO4-甲醇(25∶75);检测波长:237 nm;流速:1 mL.min-1;柱温:室温。采用浆法测定溶出度,并计算累计溶出百分率。结果:苯磺酸氨氯地平在10～70μg.mL-1的浓度范围内与峰面积线形良好,线性回归方程为:Y=18 914 X+13 640,相关系数为r=0.999 3;平均回收率为100.65%,RSD为0.99%;溶出时间为30 min时累积释放百分率达80%,符合《中华人民共和国药典》规定。结论:各项检验方法简便、准确、可靠,可作为该制剂的质量控制方法。
OBJECTIVE： To establish the study on the quality control of amlodipine besylate tablet in view of its remarkable antihypertensive efficacy so as to provide basis for the quality control of the preparation.METHODS： HPLC was employed for content determination of amlodipine besylate tablet with Phenomenex-C18 column（200 mm×4.6 mm,5 μm） at room temperature.The mobile phase consisted of 0.03 mol·L-1 KH2PO4-methanol solution（25∶75） at a flow rate of 1 mL·min-1 with the detecting wavelength set at 237 nm.The dissolution was determined by oar spectrometry with cumulative dissolution percentage computed.RESULTS： Amlodipine besylate has a good linear relationship at a concentration range of 10-70 μg·mL-1,with the standard curve equation Y=18 914 X＋13 640（r=0.999 3）,the average recoveries of 100.65%,RSD of 0.99%,and cumulative dissolution percentage of 80% at 30 min（dissolution time） which was in line with the standard of Pharmacopoeia of the People＇s Republic of China.CONCLUSION： Each determination method is simple,accurate and reliable and which can be used as the quality control method of amlodipine besylate tablet.
出处
《中国医院用药评价与分析》
2012年第3期236-238,共3页
Evaluation and Analysis of Drug-use in Hospitals of China
