摘要
目的 :建立佐米曲普坦的质量控制方法。方法 :采用反相高效液相色谱法 ,以 Shimadzu CLC- C8为分析柱 ,乙腈 - 10 mmol/ L KH2 PO4(2 5∶ 75 ,p H7.5 )溶液为流动相 ,检测波长 2 2 9nm测定佐米曲普坦的含量 ,并对其纯度进行考察。结果 :建立的方法能够有效地分离合成原料、中间体、降解产物和其它有关杂质 ,含量测定结果与非水电位滴定法结果一致 (P>0 .0 5 )。结论 :高效液相色谱法可以有效地控制佐米曲普坦中微量有关杂质 ,非水滴定法和高效液相法均可有效地控制本品的含量。
Objective: To develop an analytical method and quality control for determination of zolmitriptan and related substances. Methods: Zolmitriptan and related substances were separated and determined on a shimadzu CLC-C_8 column(150 mm×6 mm, 10 μm)with a mobile phase of acetonitrile-10 mmol/L phosphate buffer(25∶75,pH 7.5)and a flow-rate of 1 ml/min; the UV-VIS detector was operated at 229 nm. Results: The limit of detection for the related substances was 0.5 ng on the zolmitriptan basis (S/N>3).Linear calibration curve was gene-rated from 4～40 μg/ml with a correlation coefficient of 0.9999. The recovery rate of zolmitriptan was 99.1% with a standard deviation of 0.2%. The results of HPLC method were consistent with those of nonaqueous titration method. Conclusion: HPLC method is a rapid,sensitive and accurate method for the determination of zolmitriptan and its related substances.
出处
《浙江大学学报（医学版）》
CAS
CSCD
2004年第1期37-40,共4页
Journal of Zhejiang University(Medical Sciences)
关键词
佐米曲普坦
分析
色谱法
高效液相
Zolmitriptan/anal
Chromatography,high-pressure liquid
