地非三唑及其注射液的质量控制  

Quality Control of Diphenytriazol and Its Injection

作　　者：王向军[1] 姚彤炜[1] 顾少君[1] 胡云珍[1] 黄小华[1] 曾苏[1] 

机构地区：[1]浙江大学药学院药物分析与药物代谢研究室,杭州310031

出　　处：《药物分析杂志》2004年第1期59-62,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:采用高效液相色谱法测定地非三唑及其注射液的含量,为其质量控制提供快速、有效的分析手段。方法:采用汉邦公司Lichrosper ODS色谱柱(4.6 mm×250 mm,5 μm),以甲醇-10 mmol·L-1磷酸二氢钾(pH 7.5)缓冲液(6.5:3.5)为流动相;流速1.0 mL·min-1,应用二极管阵列检测器(DAD),检测波长:235 nm,进样量:20μL。结果:地非三唑浓度在0.02～0.20 mg·mL-1范围内线性关系良好(r:0.9996),平均回收率为99.98%,日内RSD为0.43%,日间RSD为1.3%,最低检测量为15 ng;样品中有关物质与主成分基线分离,中间体和降解产物不干扰测定。结论:该法专属性强,结果准确,重现性好,可用作地非三唑及其注射液含量测定和有关杂质控制的方法。Objective:To develop a method for assay and detection of diphenytriazol and its injection. Methods: Li-chrosper ODS(4. 6 mm ×250 mm,5 μm) column was applied,and mobile phase was methanol - 10 mmol·L-1 potassium dihydrogen phosphate solutions,pH 7. 5,6. 5: 3. 5). The flow rate was 1. 0 mL· min-1 ,the UV detection wavelength was 235 nm, and the injected volume was 20μL. Results: The calibration curve for diphenytriazol assay exhibited excellent linear relationship with a correlation coefficient 0. 9996 in the concentration range of 0. 02 -0. 20 mg · mL-1 with diazepam as the internal standard. The average recovery of assay was 99. 98% . The intra - day precision ( RSD ) was 0. 43 % and the inter - day precision ( RSD) was 1.3% . The detection limit was 15 ng. Conclusion : The method is simple, accurate and allows to be used as analytical method for the routine quality control of diphenytriazol and its injection.

关 键 词：地非三唑 注射液 质量控制 高效液相色谱 含量 

分 类 号：R927.2[医药卫生—药学]