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目的:建立同时测定复方罗布麻片Ⅰ中硫酸双肼屈嗪、氢氯噻嗪、盐酸异丙嗪的含量的高效液相色谱法。方法:色谱柱:Waters Sunfire C_(18)柱(250mm×4.6mm,5.0μm);流动相:0.01mol·L~(-1)己烷磺酸钠溶液-乙腈-甲醇-冰醋酸(用三乙胺调pH3.0)(53:23:23:1),流速:1.0ml·ml~(-1),检测波长:249nm。结果:硫酸双肼屈嗪在203.00～20.30μg·ml~(-1)(r=0.999 9),氢氯噻嗪在203.20～20.32μg·ml~(-1)(r=0.999 9),盐酸异丙嗪在101.60～10.16μg·ml~(-1)(r=0.999 9)浓度范围内线性关系良好;回收率分别为100.0%(RSD1.1%),100.4%(RSD0.8%),99.4%(RSD1.1%)。结论:本法操作简便、快捷、结果准确,可用于复方罗布麻片Ⅰ的质量控制。
Objective: To establish a high performance liquid chromatography (HPLC) method for the simultaneous determination of dihydralazine sulfate, hydrochlorothiazide and promethazine hydrochloride in Compound Apocynacaptic. Methods: The chromatographic column was Waters Sunfire C 18 column (250 mm × 4.6 mm, 5.0 μm). The mobile phase consisted of 0.01 mol·L -1 hexanesulfonate solution-acetonitrile-methanol-glacial acetic acid Ethylamine adjusted to pH 3.0) (53: 23: 23: 1), flow rate: 1.0 ml · ml -1, detection wavelength: 249 nm. Results: The results showed that there was a significant difference between the two groups in the range of 203.00 ~ 20.30μg · ml -1 (r = 0.999 9), those of hydrochlorothiazide between 203.20 ~ 20.32μg · ml ~ (-1) (r = 0.999 9) The linear range was from 101.60 to 10.16 μg · ml -1 (r = 0.999 9). The recoveries were 100.0% (RSD 1.1%), 100.4% (RSD 0.8%) and 99.4% RSD 1.1%). Conclusion: The method is simple, rapid and accurate. It can be used for the quality control of Compound Apocynum.