旋光法测定盐酸地尔硫原料及片剂中盐酸地尔硫的含量  

Determiantion of diltianzem hydrochloride in its tablets by polarimetric analysis

作　　者：董杰[1] 

机构地区：[1]天津田边制药有限公司,天津300385

出　　处：《天津药学》2014年第2期32-33,共2页Tianjin Pharmacy

摘　　要：目的：建立盐酸地尔硫（卓）原料及片剂中盐酸地尔硫（卓）含量测定方法.方法：以纯化水为溶剂,运用旋光法测定盐酸地尔硫草原料及片剂中盐酸地尔硫（卓）的含量.结果：盐酸地尔硫（卓）在5 ～ 30 mg/ml范围内浓度与旋光度呈良好的线性关系,回归方程为C =0.088 7 ＋0.976 3 X（r =0.998 7）,平均回收率为100.2％,RSD为0.56％（n=9）.结论：本方法简便易行,结果准确,可作为盐酸地尔硫（卓）原料及片剂的快速质量控制方法.Objectvie ：To establish a method for the content determination of dihianzem hydrochloride in raw material and tablets. Methods： The polarimetric analysis was carried out with purified water as solvent. Result： There was a good linear relationship between the concentration of diltiazem hydrochloride and the specific rotation within the range of 5mg/ml to 30 mg/ml. The regression equation was C = 0. 088 7 ＋ 0. 976 3 X（r = 0.9987）. The average recovery was 100.2% with the RSD of 0.56% （ n = 9）. Conclusion：The method is convenient,accurate and reliable. It can be used as the quality control for dihiazem hydrochloride and its tablets.

关 键 词：旋光法 盐酸地尔硫(卓) 盐酸地尔硫(卓)片 含量测定 

分 类 号：R927.2[医药卫生—药学]