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作者:康军;张鹤; (辽阳市食品药品检验所;)摘要:目的:建立测定氯雷他定片中氯雷他定含量的高效液相色谱法。方法:采用色谱柱为Diamonsil C18(200 mm×4.6 mm,5μm);流动相为乙腈-磷酸盐缓冲液(用磷酸调节pH值至3.0)(70∶30),流速为1.0 ml/min,检测波长为247 nm,柱温为25℃。结果:回归方程为Y=760 965X-82 937,r=0.999 2(n=6)。表明进样量在0.80~4.80μg范围内有良好的线性关系,平均回收率为99.60%,RSD为0.39%(n=9)。结论:本法测定氯雷他定片的含量简单、灵敏、重现性好,能够准确地控制药品质量。谱图:http://ng1.17img.cn/bbsfiles/images/2012/08/201208201407_384675_1606903_3.jpg
这次咱有奖征集氯雷他定片的照片,照片一张奖励十分,如果是网络下载的图片奖励1到3分,记得图片要清晰点哦,起码让人看到商标或者厂家嘛。我自己先来几张先。http://ng1.17img.cn/bbsfiles/images/2012/01/201201301203_346881_1645752_3.jpghttp://ng1.17img.cn/bbsfiles/images/2012/01/201201301203_346882_1645752_3.jpghttp://ng1.17img.cn/bbsfiles/images/2012/01/201201301207_346883_1645752_3.jpg 话说俺对这个制剂还是颇有感情的,那年去中检所进修就有幸接触到这个制剂,当时是要标准提高,找出一个合适的方法把这么多厂家生产的氯雷他定片都能测定出来,做的俺那是死去活来啊。
2015版药典新增和修订了多种药品的HPLC检测方法。针对这些提高和修订,默克密理博应用实验室发出了一系列的应用方法,帮助客户以最快速度满足药典的技术要求。本方案涉及氯雷他定片的含量测定。经默克应用实验室验证,完全符合2015版药典要求。该方案同时采用了传统的颗粒柱和Merck专利技术的整体柱(Chromolith色谱柱)两HPLC方法,相对于颗粒柱,整体柱方案大约节省了一半的分析时间,且方法的灵敏度更高。细节请见附件。data:image/png;base64,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