摘要
目的 建立同时测定复方地芬诺酯片中盐酸地芬诺酯和硫酸阿托品含量的高效液相色谱法。方法 采用CN柱（250mm×4．6mm，5μm）；流动相：A相（庚烷磺酸钠27．5mg，三乙胺0.8ml，水1000ml用磷酸调pH值3．00±0．02）-乙腈（25：75）；检测波长：硫酸阿托品为200nm。盐酸地芬诺酯为258nm；流量1．0ml·min^-1；进样量：10μl；柱温35℃。结果 线性范围：盐酸地芬诺酯为99．36μg·ml^-1 - 894．24μg·ml^-1，r=0．9999；硫酸阿托品为：0．984μg·ml^-1 - 8．856μg·ml^-1，r=1．0000。平均回收率：硫酸阿托品为99．2％，RSD为1．3％；盐酸地芬诺酯为99．5％，RSD为1．0％。结论 此法简便、准确、易行。
AIM To establish an HPLC method for simultaneous determination of diphenoxylate and atropine. METHOD The assay was performed on a Kromasil CN column （250 mm × 4.6 mm,5 μn）. The mobile phase was composed of A （sodium heptanesulfonate 27.5 mg,triethylamine 0.8 ml,water 1000 ml,then adjusting pH to 3.00 ± 0.02 with phosphoric acid ）-acetonitrile （25：75） ,the flow rate was 1.0 ml·min^- 1. The detection wavelength was 200 nm for atropine,then 258 nm for diphenoxylate. The column temperature was 35 ℃.RESULTS The linear ranges of diphenoxylate and atropine were 99.36 - 894.24 μg. ml^- 1 （ r = 0.9999） and 0.984 - 8.856 μg·ml^- 1 （ r = 1 ）. The average recoveries were 99.18% and 98.8% ,with RSD 1.19% and 1.14% respectively. CONCLUSION The method is simple,accurate and feasible.
出处
《江苏药学与临床研究》
2006年第6期386-388,共3页
Jiangsu Pharmacertical and Clinical Research
