盐酸哌唑嗪片质量标准改进研究  

Study on the Improvement of the Standard of Prazosin Hydrochloride Tablets

作　　者：吴珺[1] 钱忠义[1] 袁华峰 

机构地区：[1]江苏省泰州市食品药品检验所,泰州225300

出　　处：《中国药事》2015年第2期173-177,共5页Chinese Pharmaceutical Affairs

基　　金：江苏省科技公共服务平台基金计划-江苏省区域性食品药品检验检测公共技术服务中心(编号BM2012024)

摘　　要：目的：改进盐酸哌唑嗪片现行质量标准，使检测结果更准确，操作更环保。方法：建立反相高效液相色谱法测定盐酸哌唑嗪片的含量、含量均匀度和有关物质。采用Waters SunfireC18柱（4．6min×250mm，5μm），流动相为甲醇-磷酸盐缓冲液（磷酸二氢钾1．36g，加水溶解并稀释制成1000mL，加三乙胺4mL，用磷酸调节pH值至4．5）（40：60），流速：1mL·min^-1，检测波长：245nm，柱温：35℃，进样体积：10μL。结果：盐酸哌唑嗪在4．910～49．10μg·mL^-1范围内线性关系良好（r=1．000，n=6）；平均回收率为99．50％，RSD=0．70％。结论：本方法经方法学验证，可用于盐酸哌唑嗪片含量、含量均匀度测定和有关物质检查。Objective： To improve the present quality standard ofPrazosin Hydrochloride Tablets, and to increase the accuracy of the test results and the environmental friendliness of the operation. Methods： A reverse-phase HPLC method was established for the determination of the contents, content uniformity and related substances in Prazosin Hydrochloride Tablets. The Waters Sunfire C18 column （4.6 mm×250 mm, 5 μm） was adopted with the mobile phase of methanol-phosphate buffer solution （containing 0.1 mol · L-1 potassium dihydrogen phosphate and 0.4% triethylamine, adjusted to pH 4.5 with phosphoric acid） （40 ： 60）. The flow rate was 1 mL·min-1, and the detection wavelength was 245 nm. The column temperature was 35 ℃, and the volume of injection was 10 μL. Results： The linear range of Prazosin Hydrochloride was 4.910-49.10 μg·mL^11 （r=1.000, n=6）. The average recovery rate was 99.50%, RSD=0.70%. Conclusion： Verified by methodology, the method could be applied to determine the content, content uniformity and related substances in Prazosin Hydrochloride Tablets.

关 键 词：反相高效液相色谱法 盐酸哌唑嗪 含量 含量均匀度 有关物质 标准改进 

分 类 号：R927.11[医药卫生—药学]