CAJ | 학술논문

目的：建立HPLC法检查阿戈美拉汀中的主要有关物质测定方法．方法：采用Dikma—C18色谱柱（150mm×4．6mm，5μm）；以0．1％磷酸溶液（三乙胺调节pH值至3．0）-乙腈为流动相，采用梯度洗脱；流速为1mL·min-1；检测波长为231nm．结果：HPLC法能有效检出阿戈美拉汀及其胶囊中的主要杂质，最低检出限为5．17×10-4ng．结论：该方法灵敏度高、专属性好，适用于阿戈美拉汀及其胶囊的有关物质检查．
목적：건립HPLC법검사아과미랍정중적주요유관물질측정방법．방법：채용Dikma—C18색보주（150mm×4．6mm，5μm）；이0．1％린산용액（삼을알조절pH치지3．0）-을정위류동상，채용제도세탈；류속위1mL·min-1；검측파장위231nm．결과：HPLC법능유효검출아과미랍정급기효낭중적주요잡질，최저검출한위5．17×10-4ng．결론：해방법령민도고、전속성호，괄용우아과미랍정급기효낭적유관물질검사．
The present study is to establish an HPLC method for related substances test in agomelatlne anu its capsules. In the study, Dikma-C18 column （ 150 mm × 4.6 mm, 5 μm） was used, with 0.1% H3PO4 （pH 3.0, adjusted by triethanolamine）-acetonitrile as a mobile phase with gradient elution at a flow rate of 1.0 mL/min, and the detection wavelength was 231 nm. Results showed that the main related substances in agomelatine were effectively determined by HPLC, with the limit of detection at 5.17 × 10-4 ng. It is concluded that the method proposed for determination of the related substances in agomelatine and its capsules is sensitive and specific.