摘要
目的:建立高效液相色谱法测定异丙嗪胆汁片中盐酸异丙嗪的含量。方法:Diamonsil^(TM)C_(18)色谱柱(250 mm×4.6 mm,5μm,迪马公司);流动相:0.02mol·L^(-1)磷酸二氢钾缓冲溶液(取磷酸二氢钾2.72 g,加水700 mL 溶解,用磷酸调 pH 至3.0,加水至1000 mL)-乙腈-甲醇(55:20:25),流速:1.0 mL·min^(-1),检测波长:249nm,进样量:10μL。结果:盐酸异丙嗪在5.3-84.6μg·mL^(-1)浓度范围内线性关系良好,r=0.9998(n=6),平均回收率为99.90%,RSD=0.62%(n=5)结论:该法简便、灵敏、准确,专属性强,可用于异丙嗪胆汁片的质量控制。
Objective： To establish the HPLC method for determination of Promethazine Hydrochloride in Promethazine and Bile tablets. Method： The HPLC system consisted of DiamonsilTM C18 （250mm×4.6mm,5μm） , and mixture of 0. 02 mol·L^-1 potassium dihydrogen phosphate buffer solution （ dissolve 2. 72 g potassium dihydrogen phosphate in 700 mL of water, adjust to pH3.0 by H2PO4, dilute with water to 1000mL） - acetonitrilemethanol（55： 20：25 ）as mobile phase, at the flow rate of 1.0 mol·L^-1 and the detection wavelength of 249 nm and the injection volumn was 10 p.Lo Results： The linear range of Promethazine Hydrochloride was 5.3 - 84. 6μg mol·L^-1 ,the corretation coefficient was 0. 9998 （ n = 6）. The average recovery was 99.90% , （ RSD = 0. 62% ,n = 5 ） Conclusion： The method is simple, sensitive and accurate. It can be used for quality control of Promethazine and Bile tablets.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第9期1129-1131,共3页
Chinese Journal of Pharmaceutical Analysis
