摘要
目的建立氯膦酸二钠注射液的含量测定方法。方法采用阴离子交换色谱柱分离,用衍生溶液在线柱后衍生,再进行紫外检测。色谱柱为阴离子交换柱(DIONEX Ion Pac AS7分离柱,10μm,4mm×25cm;DIONEX Ion Pac AG7预柱);流动相为40mmol/L硝酸溶液,流速0.5mL/min;柱后衍生溶液为含有高氯酸的硝酸铁溶液,流速为0.25mL/min;检测波长为300nm。结果氯膦酸二钠在100~300μg/mL的浓度范围内有良好的线性关系,回归方程为P=0.00013014A+23.952,r=0.9999(n=7);平均回收率为101.85%,RSD=1.2%(n=9)。结论该方法简捷、快速、准确度高,可用于氯膦酸二钠注射液的质量控制。
Objective To establish a method for the content determination of disodium clodronate in disodium clodronate injection. Methods The separation was performed on an anion-exchange column (DIONEX IonPac AS7 analytical column, 10μm,4 mm × 25 cm; DIONEX IonPac AG7 guard columns). Derivatization solution was used for post-column derivatization online. A UV-detector was used for detection. The mobile phase consisted of 40 mmol/L HNO3 solution. The flow was 0.5 ml/min. The post-derivatization solution was ferric nitrate solution containing perchloric acid, and flow was 0.25 ml/min. The detective wavelength was 300 nm. Results Disocliu clodronate was linear in the range of 100 -300μg/ml( r = 0. 9999,n = 7). The average recovery was 101.85% with RSD of 1.2% (n =9). Conclusion This method is simple,fast and reliable for the quality control of disodium clodronate injection.
出处
《广东药学院学报》
CAS
2006年第5期516-517,523,共3页
Academic Journal of Guangdong College of Pharmacy
关键词
柱后衍生
离子色谱法
氯膦酸二钠注射液
含量测定
post-column derivatization,ion-exchange chromatography,disodium clodronate injection