论文部分内容阅读
目的:建立同时测定复方利血平片中硫酸双肼屈嗪、氢氯噻嗪、维生素B_1和维生素B_6含量的高效液相色谱法。方法:采用Hypersil BDS C_(18)柱(200mm×4.6mm,5μm);流动相为0.01mol·L~(-1)庚烷磺酸钠溶液-乙腈-甲醇-三乙胺(65:20:15:0.02),用5%磷酸溶液调节pH至3.6;检测波长为240nm。结果:硫酸双肼屈嗪在32.5～406.7μg·ml~(-1)(r=0.999 2),氢氯噻嗪在24.4～304.4μg·ml~(-1)(r=0.999 4),维生素B_1在8.5～106.6μg·ml~(-1)(r=0.999 3),维生素B_6在8.5～106.0μg·ml~(-1) (r=0.999 1)浓度范围内线性关系良好;硫酸双肼屈嗪回收率为100.2%,RSD为0.8%(n=9),氢氯噻嗪回收率为99.7%,RSD为1.0%(n=9),维生素B_1回收率为100.0%,RSD为0.9%(n=9),维生素B_6回收率为100.5%,RSD为0.9%(n=9)。结论:本法操作简便、快捷,结果准确,可用于复方利血平片的质量控制。
Objective: To establish a high performance liquid chromatography (HPLC) method for the simultaneous determination of dihydralazine sulfate, hydrochlorothiazide, vitamin B_1 and vitamin B_6 in Fufang Reserpine tablets. METHODS: Hypersil BDS C 18 column (200 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of 0.01 mol·L -1 sodium heptanesulfonate solution - acetonitrile - methanol - triethylamine (65:20: 15: 0.02) with 5% phosphoric acid to adjust the pH to 3.6; the detection wavelength was 240 nm. Results: The results showed that in the range of 32.5 ~ 406.7μg · ml -1 (r = 0.999 2), hydrochlorothiazide was 24.4 ~ 304.4μg · ml -1 (r = 0.999 4) and vitamin B_1 was 8.5 ~ 106.6μg · ml -1 (r = 0.999 3). Vitamin B 6 had a good linearity in the concentration range of 8.5 ~ 106.0μg · ml -1 (r = 0.999 1). The recovery of dihydralazine sulfate (RSD = 100.2%, RSD = 0.8% (n = 9)), hydrochlorothiazide recovery was 99.7%, RSD was 1.0% (n = 9), vitamin B_1 recovery was 100.0%, RSD was 0.9% Vitamin B_6 recovery was 100.5% with a RSD of 0.9% (n = 9). Conclusion: This method is simple, fast and accurate. It can be used for the quality control of compound reserpine tablets.