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目的:采用HPLC法测定复方罗布麻片Ⅰ中氢氯噻嗪和硫酸双肼屈嗪的含量。方法:用Shim-pack C_(18)色谱柱(250 mm×4.6mm,5μm),流动相为:0.14%庚烷磺酸钠(取庚烷磺酸钠1.4g及磷酸氢铵0.8 g,溶于1000 ml水中,用磷酸调pH 3.0)-乙腈(82:18),检测波长为254 nm,流速1.0 ml·min~(-1)。结果:氢氯噻嗪和硫酸双肼屈嗪的线性范围分别为30.9～154.5μg·ml~(-1)(r=0.999 8)和31.0～156.0μg·ml~(-1)(r=0.999 9),平均回收率分别为100.4%和103.2%,RSD分别为0.9%和0.8%(n=6)。结论:方法结果准确,重复性好,可用于复方罗布麻片Ⅰ的质量控制。
OBJECTIVE: To determine the contents of hydrochlorothiazide and hydralazine sulfate in Compound Apocynum Ⅰ by HPLC. Methods: Shim-pack C_ (18) column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of 0.14% sodium heptane sulfonate (1.4 g heptane sulfonate and 0.8 g ammonium hydrogen phosphate In 1000 ml water, adjust pH to 3.0 with phosphoric acid - acetonitrile (82:18). The detection wavelength was 254 nm and the flow rate was 1.0 ml · min -1. Results: The linear ranges of hydrochlorothiazide and hydralazine sulfate were 30.9-154.5 μg · ml -1 (r = 0.999 8) and 31.0-156.0 μg · ml -1 (r = 0.999 9), respectively. The average recoveries were 100.4% and 103.2%, respectively, with RSDs of 0.9% and 0.8%, respectively (n = 6). Conclusion: The method is accurate, reproducible and can be used for the quality control of Compound Apocynum.