HPLC法测定佐匹克隆片的含量及有关物质

目的:用高效液相色谱法测定佐匹克隆片的含量及有关物质.方法:用C18柱;流动相:pH3.5缓冲溶液(取十二烷基硫酸钠8.1 g和磷酸二氢钠1.6 g,加水1 000 mL使溶解,用磷酸调pH3.5)-乙腈(55:45);检测波长:303nm.采用外标法测定含量,加校正因子的自身对照法测定已知杂质,自身对照法测定未知杂质.结果:佐匹克隆浓度在19.04～152.29mg·L-1范围内与峰面积呈良好的线性关系,r=0.9997.平均加样回收率为99.6%,RSD=0.8%(n=5).有关物质各杂质峰与主峰之间的分离度良好;结论:本方法灵敏度高,专属性强、准确可靠,适合于佐匹克隆片含量及有关物质的测定.

Determination of Zopiclone and Related Substances in Zopiclone Tablets by HPLC

Objective: To determine the content and the related substances in Zopiclone Tablets by HPLC.Methods: C₁₈ column;Mobile phase:pH 3.5 buffer solution(Add 8.1 g of sodium dodecyl sulfate and 1.6 g of Sodium Dihydrogen Phosphate was soluble in 1 000mL of water and adjusted to pH 3.5 with phosphoric acid.)-acetonitrile(55:45);Detective wavelength:303 nm.External standard method was used in content determination,the self-calibrated method with calibration factor was used to determine the known imputities and the self-calibrated method for the unknown impurities.Results: There is a good linear relationship in the range of 19.04~152.29 mg·L^-1,r=0.999 7.The average recovery rate was 99.6% with RSD 0.8%(n=5).Conclusion: This method is sensitive,specific and reliable.It can be the method to control the quality.