佐匹克隆原料及片剂有关物质的HPLC测定

Determination of Related Substances of Zopiclone and Its Tablets by HPLC

目的建立HPLC测定佐匹克隆原料及片剂的有关物质。方法采用Phenomenex C18柱,以乙腈-混合溶液[含8.1 g.L-1十二烷基磺酸钠(SDS)和1.6 g.L-1磷酸二氢钠,用10%磷酸调至pH3.5](40∶60)为流动相,检测波长为303 nm。结果佐匹克隆的定量限和检测限分别为33和11 ng。结论本方法准确、简便、专属性强,可用与药品质量控制。

OBJECTIVE To establish a HPLC method for the determination of related substances of zopiclone and its tablets. METHODS A phenomenex C18 column was used with the mobile phase of acetonitrle buffer（consisted of 8. 1 g·L^-1 SDS and 1.6 g·L^-1 sodium dihydrogen phosphate, adjusted to pH 3.5 with 10% phosphoric acid）（40： 60）, at the detection wavelength of 303 nm. RESULTS The quantitation and detection limits were 33 and 11 ng, respectively. CONCLUSION This method is accurate, simple and selective for the quality evaluation and control .