高效液相色谱法同时测定经皮渗透液中美托洛尔和非洛地平的含量  

Simultaneous Determination of Metoprolol Tartrate and Felodipine in Skin Diffuse Solution by HPLC

作　　者：王文刚[1] 恽榴红[1] 王睿[2] 周筱青[2] 

机构地区：[1]军事医学科学院毒物药物研究所,北京100850 [2]解放军总医院临床药理研究室,北京100853

出　　处：《中国药学杂志》2006年第2期143-146,共4页Chinese Pharmaceutical Journal

摘　　要：目的建立同时测定体外经皮渗透液中酒石酸美托洛尔和非洛地平含量的高效液相色谱分析方法。方法采用Phe- nomenex prodigy ODS(3)色谱柱(4．6 mm×250 mm,5μm),流动相为甲醇-10 mmol·L-1庚烷磺酸钠溶液(68:32),冰醋酸调pH至 3．5,检测波长223 nm,流速1 mL·min-1。采用外标法测定体外经皮渗透液中酒石酸美托洛尔和非洛地平的含量。结果美托洛尔和非洛地平标准曲线的线性范围分别为1-10和0．1-8mg·L-1;平均回收率分别为100．15％-100．39％和99．71％- 103．83％,日内RSD分别为0．19％-0．33％和0．13％-1．57％,日间RSD分别为0．45％-0．54％和0．28％-1．89％(n=15)。结论本方法快速、简便,重现性好,结果准确可靠,适用于体外经皮渗透液中酒石酸美托洛尔和非洛地平含量的测定。OBJECTIVE To develop a HPLC assay for simultaneously determining metoprolol tartmte and felodipine in permeation solution.METHODS A phenomenex prodigy ODS（3） column （4.6 mm×250 mm,5μm） was used and the mobile phase consisted of methanol- 10mmol·L-1 sodium 1-heptanesulfonate（68：32）,pH was adjusted to 3.5 with glacial acetic acid.The detection wavelength was 223 nm and the flow rate was 1 mL·min^-1. The content was calculated using external standard method. RESULTS The linear range of metoprolol tartrate was 1-10 mg·L^-1 and that of felodipine was 0.1-8 mg·L^-1. The recoveries of methodology metoprolol tartrate were 100.15%-100.39 % and those of felodipine were 99.71%-103.83%, the interday validation and the intraday validation of metoprolol tartrate were 0.19%-0.33% and 0.45%-0.54% and those of felodipine were 0.13%-1.57% and 0.28%- 1.89% （n=15）, respectively.CONCLUSION The HPLC assay is rapid, simple, convenient, accurate, reproducible and reliable and reliable for simuhaneously quantitative analysis of metoprolol tartmte and felodipine in permeation solution.

关 键 词：高效液相色谱法 酒石酸美托洛尔 非洛地平 经皮渗透 

分 类 号：R917[医药卫生—药物分析学]