高效液相色谱法测定二维三七桂利嗪胶囊中维生素B_(6)和桂利嗪的含量

Determination of Vitamin B_(6) and Cinnarizine in Divitamins Notoginseng and Cinnarizine Capsules by HPLC

目的用高效液相色谱法测定二维三七桂利嗪胶囊中维生素B_(6)和桂利嗪的含量。方法用十八烷基硅烷键合硅胶(C_(18))为填充柱,以5mmol/L十二烷基硫酸钠(用冰醋酸调节pH至3.0)-甲醇(25︰75)为流动相,流速1.0 m L/min,柱温35℃,采用二极管阵列检测器同时在251 nm、292nm波长处进行检测,外标法定量。结果维生素B6和桂利嗪分离度大于1.5,线性范围为0.01~0.31mg/m L(r=0.9997)和0.03~0.89mg/m L(r=0.9996),加样回收率为100.5%和99.2%。结论该方法准确稳定,可用于该制剂的质量控制。

Objective:To establish a high-performance liquid chromatography(HPLC)method for content determination of vitamin B_(6) and cinnarizine in divitamins notonginseng and cinnarizine capsules.Methods:C_(18) column which was set at 35℃ was used for the separation with 5 mmol/L sodium dodecyl sulfate solution(pH was adjusted to 3.0 with glacial acetic acid)-methanol(25︰75)as the mobile phase at the flow rate of 1.0 m L/min.The diode array detector was used for detection at the wavelengths of 251 nm and 292 nm at the same time,and the external standard method was used for quantification.Results:The resolution of vitamin B6 and cinnarizine was greater than 1.5,and the linear ranges were 0.01~0.31 mg/m L(r=0.9997)and 0.03~0.89 mg/m L(r=0.9996),respectively.The recoveries of vitamin B6 and cinnarizine were 100.5% and 99.2%,respectively.Conclusion:The method is accurate and stable,which can be used for the quality control of the preparation.