CAJ | 학술논문

建立了HPLC法测定盐酸纳美芬注射液中有关物质盐酸纳曲酮和双纳美芬的含量.采用C_(18)柱,乙腈-0.05 mol/L磷酸盐缓冲液(20:80,含0.2%三乙胺,85%磷酸调至pH 4.2)为流动相,检测波长210 nm.盐酸纳曲酮和双纳美芬均在0.1～1.5 μg/ml浓度范围内,线性关系良好(r均为0.9994).盐酸纳美芬、盐酸纳曲酮和双纳美芬的检测限分别为0.2、0.4和0.04ng.
건립료HPLC법측정염산납미분주사액중유관물질염산납곡동화쌍납미분적함량.채용C_(18)주,을정-0.05 mol/L린산염완충액(20:80,함0.2%삼을알,85%린산조지pH 4.2)위류동상,검측파장210 nm.염산납곡동화쌍납미분균재0.1～1.5 μg/ml농도범위내,선성관계량호(r균위0.9994).염산납미분、염산납곡동화쌍납미분적검측한분별위0.2、0.4화0.04ng.
An HPLC method was established for the determination of related substances, nalterxone hydrochloride and bisnalmefene, in nalmefene hydrochloride injection. A C_(18) column was used with the mobile phase of acetonitrile-0.05 mol/L phosphate buffer (20:80, containing 0.2% triethylamine, adjusted to pH 4.2 by 85 % phosphoric acid), at the detection wavelength of 210 nm. The calibration curves of nalterxone hydrochloride and bisnalmefene were linear in the concentration range of 0.1-1.5 μg/ml (r=0.999 4). The detection limits of nalmefene hydrochloride, nalterxone hydrochloride and bisnalmefene were 0.2,0.4 and 0.04 ng, respectively.