改进中国药典方法测定苦木注射液中聚山梨酯80的含量

Determination of Polysorbate 80 in Kumu Injection by Improved Method of Chinese Pharmacopoeia

目的建立苦木注射液中聚山梨酯80含量测定的可行性方法。方法采用硫氰酸钴铵比色法,制备标准曲线溶液、供试品溶液,分别在623 nm下测定吸光度,用标准曲线法计算含量。结果聚山梨酯80在0.4~1.2 mg·mL^-1浓度范围内,吸光度与浓度呈良好线性关系(r=0.9998);各浓度水平下的平均回收率为92%~105%,RSD为0.9%。结论本方法专属性强,精密、准确,可用于苦木注射液中聚山梨酯80的含量测定。

OBJECTIVE To establish a feasible method for the determination of polysorbate 80 in Kumu injection.METHODS Standard curve solution and sample solution were prepared by cobalt ammonium thiocyanate colorimetry method.The absorbance was measured at 623 nm,and the content was calculated by standard curve method.RESULTS In the concentration range of 0.4-1.2 mg·mL^-1,the absorbance showed a good linear relationship with the concentration(r=0.9998).The average recovery was 92%-105%,and RSD was 0.9%.CONCLUSION The established method is specific,precise and accurate,and can be used for the determination of polysorbate 80 in Kumu injection.