HPLC法同时测定复方利血平片中硫酸双肼屈嗪等5种成分

Simultaneous Determination of Dihydralazine Sulfate et al Five Components in Compound Reserpine Tablets by HPLC

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B1、维生素B6和泛酸钙5个成分的高效液相色谱法。方法：采用Inertsil ODS-SP（4.6mmx250mm,5μm）色谱柱,以缓冲液（0.11%己烷磺酸钠,0.02%庚烷磺酸钠混合溶液,每1000mL加0.2mL三乙胺,用5%磷酸溶液调节pH值至3.5）-乙腈-甲醇（70∶10∶20）为流动相,检测波长为210nm。结果：硫酸双肼屈嗪、氢氯噻嗪、维生素B1、维生素B6、泛酸钙的浓度分别在8.4~126.8μg/mL（r=0.9997）、6.3~94.3μg/mL（r=0.9997）、2.0~29.5μg/mL（r=0.9997）、2.0~29.5μg/mL（r=0.9996）、2.2~29.8μg/mL（r=0.9996）范围内线性良好。平均回收率为96.5%~99.0%,RSD为0.6%~1.3%（n=15）。结论：该方法可用于复方利血平片中硫酸双肼屈嗪、氢氯噻嗪、维生素B1、维生素B6、泛酸钙的测定。

Objective：A HPLC method for simultaneously determining five components（Dihydralazine sulfate,Hydrochlorothiazide,Vitamin B 1,Vitamin B 6,Calcium Pantothenate） in Compound Reserpine Tablets is established.Method：Inertsil ODS-SP（4.6mm×250mm,5μm） column was adopted and diluted with,the mobile phases consisted of（0.11% sodium heptanesulfonate solution and 0.02% Hexane-1-sulfonic sodium salt,triethylamine 0.2ml/1000ml;pH value was adjusted to 3.5 with 5% phosphoric acid）-acetonitrile-methanol（70：10：20）,the flow rate was 0.7 mL/min,at the detection wavelength of 210nm.Result：The method was developed with a good linearity within the range of 8.4-126.8μg·mL-1（r=0.9997）,6.3-94.3μg·mL-1（r=0.9997）,2.0-29.5μg·mL-1（r=0.9997）,2.0-29.5μg·mL-1（r=0.9996）,2.2-29.8μg·mL-1（r=0.9996） for Dihydralazine sulfate,Hydrochlorothiazide,Vitamin B 1,Vitamin B 6 and Calcium Pantothenate respectively.And the average recoveries of the five comporents were in the range of 96.5%-99.0%,RSDs were in the range of 0.6%-1.3%（n=15）.Conclusion：The method is simple and accurate,it can be used for quantification of the five components in Compound Reserpine Tablets.