摘要
目的建立高效液相色谱法(HPLC)测定佐匹克隆片有关物质含量的方法。方法采用C18柱,以含0.5%w/v十二烷基硫酸钠的0.01%w/v磷酸二氢钠溶液(用磷酸调节p H至4.0)—乙腈(62.5∶37.5)为流动相;检测波长为303 nm。结果佐匹克隆的检测限为2.4 ng,杂质2-氨基-5-氯吡啶的检测限为0.6 ng,定量限为2 ng;2-氨基-5-氯吡啶在0.1~10μg/ml浓度范围内线性关系良好,相关系数r=1.0000;各降解杂质与主药分离良好;低、中、高浓度下的平均加样回收率分别为103.41%、101.15%和100.95%,相对标准偏差为5.0%,回收率良好;供试品溶液在25℃环境中不稳定,需4℃保存进样。结论 HPLC方法灵敏度、准确度高,专属性强,可用于佐匹克隆片的有关物质检测。
Objective To establish methods for determination of related substances in zopiclone tablets by HPLC.Methods Used C18 column,The mobile phase consisted of 0. 5% w / v of sodium dodecyl sulphate and 0. 01% w / v of sodium dihydrogen orthophosphate previously adjusted to p H 4. 0 with orthophosphoric acid and acetonitrile（ 62. 5∶ 37. 5）. The detection wavelength was 303 nm. Results The detection limit of zopiclone was 2. 4 ng,the detection limit of impurity 2-amino-5-chloropyridine was 0. 6ng,and the limit of quantitation was 2 ng. There was a good linear relationship of 2-Amino-5-chloropyridine in the range of 0. 1 ~ 10 μg / ml（ r = 1. 0000）. The degradation substances could be well separated from the main peak.The mean recovery rates of low,middle and high concentration were 103. 4%,101. 15% and 100. 95%（ RSD = 5. 0%）. The sample should be stored in 4 ℃ instead of 25 ℃. Conclusion This method is sensitive,accurate and specific for quality control of zopiclone tablets.
作者
范松华
金慧
FAN Songhua JIN Hui(Department of Pharmaceutical Biotechnology , Shanghai Pharmaceutical School, Shanghai 200135, China)
出处
《临床合理用药杂志》
2017年第1期35-36,38,共3页
Chinese Journal of Clinical Rational Drug Use
关键词
佐匹克隆
物质含量
高效液相色谱法
Zopiclone
Substance content
High performance liquid chromatography
