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目的:建立同时测定复方三嗪芦丁片中维生素B6、氢氯噻嗪、芦丁、盐酸异丙嗪、利血平含量的方法。方法:采用高效液相色谱法。色谱柱为ZORBAX SB-C18,流动相为乙腈-0.2%磷酸溶液(梯度洗脱),流速为1.5 ml/min,检测波长为291 nm(0~3 min,维生素B6)、273 nm(3~5 min,氢氯噻嗪)、251 nm(5~11 min,芦丁和盐酸异丙嗪)、218 nm(11 min,利血平),柱温为30℃,进样量为20μl。结果:维生素B6、氢氯噻嗪、芦丁、盐酸异丙嗪和利血平检测质量浓度线性范围分别为84.0~1 344.0μg/ml(r=0.999 8)、171.0~2 736.0μg/ml(r=0.999 2)、428.0~6 848.0μg/ml(r=0.999 9)、173.5~2 776.0μg/ml(r=0.999 5)、5.03~80.48μg/ml(r=0.999 1);定量限分别为18.80、14.92、25.70、12.20、4.99 ng,检测限分别为5.54、4.50、8.04、3.66、1.50 ng;精密度、稳定性、重复性试验的RSD<1.0%;加样回收率分别为98.20%~100.60%(RSD=0.89%,n=6)、99.11%~100.28%(RSD=0.39%,n=6)、99.07%~100.12%(RSD=0.38%,n=6)、98.27%~99.70%(RSD=0.50%,n=6)、97.41%~99.40%(RSD=0.88%,n=6)。结论:该方法简便、准确、灵敏度高、重复性好,可用于同时测定复方三嗪芦丁片中维生素B6、氢氯噻嗪、芦丁、盐酸异丙嗪、利血平的含量。
Objective: To establish a method for the simultaneous determination of vitamin B6, hydrochlorothiazide, rutin, promethazine hydrochloride and reserpine in compound triazine rutin tablets. Methods: Using high performance liquid chromatography. The mobile phase consisted of acetonitrile-0.2% phosphoric acid solution (gradient elution) at a flow rate of 1.5 ml / min with a detection wavelength of 291 nm (0-3 min, vitamin B6) and 273 nm 5 min, hydrochlorothiazide), 251 nm (5-11 min, rutin and promethazine hydrochloride) and 218 nm (11 min, reserpine). The column temperature was 30 ℃ and the injection volume was 20μl. Results: The linear range of the concentrations of vitamin B6, hydrochlorothiazide, rutin, promethazine hydrochloride and reserpine was 84.0 ~ 1 344.0μg / ml (r = 0.999 8), 171.0 ~ 2736.0μg / ml (R = 0.999 9), 173.5-2 276.0 μg / ml (r = 0.999 5) and 5.03-80.48 μg / ml (r = 0.999 1) respectively. The limits of quantitation were 18.80, The detection limits were 5.54, 4.50, 8.04, 3.66 and 1.50 ng, respectively. The RSDs of precision, stability and repeatability were less than 1.0% and the recoveries were 98.20% -100.60% (RSD = 0.89%, n = 6), 99.11% -100.28% (RSD = 0.39%, n = 6), 99.07% -100.12% (RSD = 0.38%, n = 6) and 98.27% -99.70% = 0.50%, n = 6), 97.41% -99.40% (RSD = 0.88%, n = 6). Conclusion: The method is simple, accurate, sensitive and reproducible. It can be used for the simultaneous determination of vitamin B6, hydrochlorothiazide, rutin, promethazine and reserpine in compound triazine rutin tablets.