吡罗昔康片质量标准中含量均匀度检测方法修订探讨  

Discussion on Revision of Detection Methods for Content Uniformity in Quality Standard of Piroxicam Tablets

作　　者：仝桂平 郑兆显 刘延娟 

机构地区：[1]山东省菏泽市食品药品检验中心,菏泽274000

出　　处：《中国药事》2014年第7期766-769,共4页Chinese Pharmaceutical Affairs

摘　　要：目的《中国药典》采用紫外分光光度法测定吡罗昔康片的含量及含量均匀度,本研究探讨HPLC法用于吡罗昔康片含量及含量均匀度检测的可行性.方法 色谱柱：Agilent ZORBAX SB-C18 （4.6 mm×250 mm,5μm）,流动相：乙腈-0.5％冰醋酸（60∶40）,检测波长：243 nm,流速：1.0 mL·min^-1,柱温：30℃.并将本研究建立的方法与原标准[1]的方法进行了比较分析.结果 采用HPLC法,吡罗昔康在5.71～57.10 μg·mL^-1范围内线性关系良好（r=0.9998）,平均回收率为99.0％ （RSD=0.6％,n=9）.该方法测定结果与紫外分光光度法比较,含量均匀度分别是10.9、10.8、10.1与11.8、10.5、10.6.结论 所建立的HPLC方法符合方法学考核要求,可用于吡罗昔康片中含量及含量均匀度的检测,可为该药品质量标准修订提供参考.Objective Chinese Pharmacopoeia adopts UV spectrophotometry to detect the content and content uniformity of piroxicam. In this article, the feasibility of using HPLC method for detecting the content and content uniformity of piroxicam was studied. Methods The chromatographic column Agilent ZORBAX SB-C18 （4.6 min×250 mm, 5μm） was used with the mobile phase consisting of acetonitrile-glacial acetic acid （0.5%） （60 ： 40）. The detection wavelength was 243 nm, the flow rate 1.0 mL ·min^-1 , the column temperature 30 ℃. The results of the method established in this paper were compared with the results of original standard methods. Results The linear range was 5.71-57. 10μg · mL^-1 （r=0. 9998）. The average recovery was 99.0% （RSD was 0. 6 %, n=9）. The content uniformity of HPLC and UV spectrophotometry was 10.9, 10.8, 10. 1 and 11.8, 10.5, 10.6, respectively. Conclusion The HPLC method meets the requirements of methodology, hence it can be used for the detection of the content and content uniformity of piroxicam tablets and may provide a reference for the modification of pharmaceutical quality standards.

关 键 词：高效液相色谱法 吡罗昔康片 含量均匀度 质量控制 标准研讨 

分 类 号：R927.2[医药卫生—药学]