酸性色素比色法测定盐酸苯环壬酯片的质量分数及溶出度  

The Acid Dye Spectrophotometric Method for the Determination of Drug Content and Dissolution of Phencynonate Hydrochloride Tablets(PHT)

作　　者：顾明冬[1] 

机构地区：[1]盐城卫生学校,江苏盐城224006

出　　处：《淮海工学院学报（自然科学版）》2000年第4期35-37,共3页Journal of Huaihai Institute of Technology:Natural Sciences Edition

摘　　要：采用溶剂萃取、酸性色素比色法测定盐酸苯环壬酯片的质量分数及溶出度 ,检测波长 41 3nm,溶出度以转篮法测定 ,转速 1 0 0 r·min-1,溶出介质 50 0 m L,p H3的磷酸盐缓冲液。结果表明 :在 3.0～ 1 5.0 mg·L-1范围内线性良好 ,r=0 .9999(n=5) ,平均回收率 99.95% (n=9) ,RSD为±0 .65%。片剂 30 min定时取样测定 ,主药溶出 90 %以上。此方法简便、准确、专属 ,可作为该制剂的质量分数测定和质量控制。To determine the content and dissolution of phencynonate hydrochloride tablets(PHT), the solvent extraction acid dye spectrophotometric method is used with the wavelength being 413 nm. The basket method is used to determine the dissolution, the rotative velocity is 100 r·min -1 and the solvent is 500 mL of phosphate buffer solution(pH 3).Results show that the linear range of the standard curve is 3.0~15.0 mg·L -1 , r =0.999 9 and n =5. The average recovery rate is 99.95% with a relative standard deviation of 0.65%( n =9). The drug dissolution rate for 30 min is over 90%. It is concluded that this method is convenient, accurate and specific for the content determination of PHT.

关 键 词：盐酸苯环壬酯片 酸性色素比色法 质量分数 测定 溶出度 抗胆碱能药 溶剂萃取 转篮法 

分 类 号：R975.5[医药卫生—药品] R927.11[医药卫生—药学]