HPLC法测定不同厂家盐酸环丙沙星片的含量及其溶出度  

Determination of ciprofloxacin hydrochloride tablets in different factories content and dissolution by HPLC

作　　者：刘秋月[1] 王莉[1] 齐永秀[1] 李珂[1] 

机构地区：[1]泰山医学院药学院,山东泰安271016

出　　处：《泰山医学院学报》2016年第2期124-126,共3页Journal of Taishan Medical College

摘　　要：目的建立盐酸环丙沙星的高效液相色谱测定法,对盐酸环丙沙星片剂进行含量及溶出度测定。方法采用高效液相色谱法,色谱柱为Hypersil ODS2-C18（250 mm×4.6 mm,5μm）,流动相为0.05 mol/l枸橼酸溶液-甲醇（70∶30）,用三乙胺调p H值为3.0,流速为1.0 ml/min,检测波长为276 nm,进样量20μl。结果环丙沙星标准溶液在3.20～12.80μg/ml范围内浓度与峰面积线性关系良好（r=0.9994）;盐酸环丙沙星片的平均回收率分别为94.72%（RSD=0.75%,n=9）,93.72%（RSD=0.65%,n=9）,93.08%（RSD=0.83%,n=9）;浙江亚太药业股份有限公司、JINGXIN、济南东方制药厂、山东健康制药有限公司的盐酸环丙沙星片的标示量的百分含量分别为94.75%、101.82%、98.02%、103.2%;浙江亚太药业股份有限公司、JINGXIN、济南东方制药厂的盐酸环丙沙星片的溶出度分别为106.70%、96.84%、109.48%。结论该含量测定方法准确,快速,有效,重现性较好,可用于盐酸环丙沙星片含量及其溶出度的测定。Objective： To establish a HPLC method for Ciprofloxacin hydrochloride tablets,to determin content and dissolution of Ciprofloxacin hydrochloride Tablets. Method： HPLC method was adopted,The determination was performed on Hypersil ODS2- C18（ 250 mm × 4. 6 mm,5μm） column with mobile phase consisted of 0. 05 mol/l Citric acid solution-methanol（ 70∶ 30）,used triethylamine adjust the solution p H3. 0,at flow rate of 1. 0 ml / min,the detection wavelength was set at 276 nm,the sample size is 20 μl. Results： Ciprofloxacin standard solution has good Linear relationship between concentration and peak areain in the range of 3. 20 ～ 12. 80 μg / ml（ r = 0. 9994）; Average recovery rate of ciprofloxacin hydrochloride tablets were 94. 72%（ RSD = 0. 75%,n = 9）,93. 72%（ RSD = 0. 65%,n = 9）,93. 08%（ RSD = 0. 83%,n= 9）; Percentage of the labeled amount of Ciprofloxacin hydrochloride tablets in Zhejiang Asia Pacific pharmaceutical Limited by Share Ltd,JINGXIN,Ji＇nan Oriental pharmaceutical factory,and Shandong Health Pharmaceutical Co.,Ltd. were94. 75%,101. 82%,98. 02%,103. 2%; Dissolution degree of ciprofloxac hydrochloride tablets in Zhejiang Asia Pacific pharmaceutical Limited by Share Ltd.,JINGXIN and Ji ＇nan Oriental pharmaceutical factory were 106. 70%,96. 84%,109. 48%. Conclusion： The content determination method is accurate,fast,effective and reproducible,and can be used to determine the content and dissolution rate of ciprofloxacin hydrochloride tablets.

关 键 词：盐酸环丙沙星 HPLC法 含量测定 溶出度 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]