拉曼光谱法测定氯膦酸二钠注射液的含量  

Quantitative determination of clodronate disodium injection by Raman spectroscopy

作　　者：姚丹丹[1,2] 张锐[3] 石蓓佳[4] 纪宇[4] 王玉[1,4] 

机构地区：[1]中国药科大学,南京210009 [2]盐城药品检验所,盐城224002 [3]江西中医药大学现代中药制剂教育部重点实验室,南昌330004 [4]江苏省食品药品检验所,南京210008

出　　处：《药物分析杂志》2014年第2期364-367,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：建立拉曼光谱法测定氯膦酸二钠注射液的含量的方法。方法：利用拉曼散射原理，在水溶液中，拉曼峰信号的强度与溶质分子的浓度成正比，选取样品溶液拉曼光谱中氯膦酸二钠的P=O基团振动（1079 cm^-1）处的强峰作为定量峰，建立拉曼光谱法测定氯膦酸二钠注射液含量的方法。结果：氯膦酸二钠在2-100 mg·mL^-1范围内与拉曼峰强度呈良好的线性关系，线性回归方程为Y=426.0X＋286.6，相关系数为0.9999（n=8），平均回收率为102.8%，RSD为1.6%（n=9）。结论：本方法操作简便、快速，可用于氯膦酸二钠注射液的含量测定。Objective： To establish a Raman method for the determination of clodronate disodium injection. Methods： Based on the Raman scattering theory that the light intensity of the laser Raman peak is in proportional to the concentration of clodronate disodium samples in aqueous solution, a quantitative method for determination of clodronate disodium injection using Raman spectroscopy was established by selecting the Raman peak of clodronate disodium P=O bond （P=O[1079 cm^-1]） as the quantitative peak. Results： The calibration curve was linear over the range of 2-100 mg·mL^-1 （r= 0.9999,n=8）,and the average recovery was 102.8% with RSD of 1.6% （n=9）. Conclusion： The method is convenient and rapid,which can be used for the quality control of clodronate disodium injection.

关 键 词：激光拉曼光谱 氯膦酸二钠 注射剂 含量测定 专属性 

分 类 号：R917[医药卫生—药物分析学]