HPLC法测定盐酸氯米帕明缓释微丸的含量

Determination of clomipramine hydrochloride in sustained-release pellets by HPLC

目的建立盐酸氯米帕明缓释微丸的含量测定方法。方法采用反相高效液相色谱法,流动相为乙腈∶0.02mol/L磷酸二氢钾溶液∶三乙胺(体积比57∶43∶0.4,pH3.0);柱温35℃;流速1.2ml/min;检测波长为251nm。结果缓释微丸中的辅料对盐酸氯米帕明的测定无干扰;盐酸氯米帕明在5.0-80mg/ml范围内线性关系良好,以盐酸氯米帕明药物浓度C(μg/ml)对峰面积A对进行线性回归,A=19.823C-8.8123,r=0.9999;日内、日间精密度相对标准偏差(RSD)均小于2%;平均回收率为98%-102%。结论该方法检测盐酸氯米帕明缓释微丸含量的精密度、准确度等均符合中国药典规定,可用于盐酸氯米帕明缓释微丸的含量测定及稳定性研究。

Objective To establish a method for determining clomipramine hydrochloride in sustained-release pellets. Methods A high performance liquid chromatography（ HPLC ）method was established with acetonitrile -0.02 mol/L potassium dihydrogen phosphate buffer- triethylanmine（43： 57： 0.4,pH 3.0）as the mobile phase. The column oven temperature was 35 ℃ ,the flow rate of mobile phase was 1.2 ml/min, and the detector wavelength was set at 251 nm. Results The excipients used in the sustained-released pellets did not interfere with the quantitation of clomipramine hydrochloride. The clomipramine hydrochloride showed a good linearity in the rage of 5.0 - 80 mg/ml （A = 19. 823 C - 8.812 3, r = 0. 999 9）. The RSD of precision was less than 2%. The mean recovery was 98% - 102%. Conclusion The precision,accuracy and reproducibility of the HPLC method could meet the requirement of China Pharmacopeia. The method could be used to determine clomipramine hydrochloride in sustained-release pellets and to investigate the stability of the preparation.