CAJ | 학술논문

采用抑制型电导检测-离子色谱法同时测定氯膦酸二钠及其制剂的含量和有关物质.色谱条件为阴离子交换色谱柱(IonPac AS11-HC);检测方式为抑制电导检测;柱温30 ℃;流速1.2 mL/min;以KOH溶液为淋洗液,含量测定采用等度洗脱,有关物质检查采用梯度洗脱.氯膦酸二钠在0.0568～0.1895 g/L范围内线性关系良好(r＝0.9999); 注射液和胶囊的平均回收率分别为100.1%(RSD=0.7%)和98.9%(RSD=0.6%);检出限为0.3 ng.各杂质与主成分色谱峰能完全分离.
채용억제형전도검측-리자색보법동시측정록련산이납급기제제적함량화유관물질.색보조건위음리자교환색보주(IonPac AS11-HC);검측방식위억제전도검측;주온30 ℃;류속1.2 mL/min;이KOH용액위림세액,함량측정채용등도세탈,유관물질검사채용제도세탈.록련산이납재0.0568～0.1895 g/L범위내선성관계량호(r＝0.9999); 주사액화효낭적평균회수솔분별위100.1%(RSD=0.7%)화98.9%(RSD=0.6%);검출한위0.3 ng.각잡질여주성분색보봉능완전분리.
A new ion chromatography was developed for the determination of clodronate disodium and its related substances. A suppressed conductivity detection was used. The analytical column was an IonPac AS11-HC anion-exchange column. The column temperature was maintained at 30 ℃. The potassium hydroxide solution was used as the eluent at a flow rate of 1.2 mL/min. For the determination of content and related substances,an isocratic elution program and a gradient elution program were performed, respectively.A good linear relationship was observed in the concentration range of clodronate disodium of 0.0568-0.1895 g/L(r=0.9999). The average recoveries of the injection and the capsules were 100.1%(RSD=0.7%) and 98.9%(RSD=0.6%),respectively. The limit of detection was 0.3 ng. The related substances gained a completely chromatography separation with the principal peak. The present method is accurate, sensitive and simple, which provides a new reliable analytical method for the quality control of clodronate disodium and its preparations.