HPLC法测定复方环磷酰胺胶囊中环磷酰胺的含量
HPLC,,HPLC；环磷酰胺；复方环磷酰胺胶囊,1材料,2方法与结果,3讨论,参考文献
摘 要 目的 建立复方环磷酰胺胶囊中环磷酰胺的含量测定方法。方法 采用高效液相色谱法，色谱柱Kromasil 100-5 C18(5 μm，4.6 mm×150 mm)，流动相为ψ(pH=3的0.3%二乙胺∶乙腈)=70∶30，内标物为对羟基苯甲酸乙酯，流速1.0 mL/min，紫外检测波长195 nm，柱温20 ℃，内标法定量。结果 环磷酰胺在199.7~998.4 μg/mL之间线性关系良好，回归方程为Y=1.3123X+0.0101，r=0.9999(n=5)，平均回收率为99.93%，RSD=1.19%(n=9)。。结论 本法简便、准确、可靠，可作为控制复方环磷酰胺胶囊质量标准的方法。关键词 HPLC；环磷酰胺；复方环磷酰胺胶囊
Assaying of cyclophosphamide in compound cyclophosphamide capsules by HPLC
BIAN Xiaolan，ZHAI Qing
(Dept.of Pharmacy, Shanghai Ruijin Hospital Affliated to Shanghai Second Medical University，Shanghai 200025)
Abstract Objective To establish a method for assaying of cyclophosphamide in compound cyclophosphamide capsules. Methods A HPLC method was utilized.The sample was separated on a Kromasil 100-5 C18 column (5 μm, 4.6 mm×150 mm) and detected at 195nm, using mixture of 0.3% diethylamine (pH=3)acetonitrile (70∶30) as the mobile phase and ethylparaben as the internal standard, the flow rate was 1.0 mL/min, and the column temperature was kept at 20 ℃. The contents were calculated with internal standard. Results The calibration curve was linear within the range from 199.7 to 998.4 μg/mL, Y=1.3123X+0.0101, r=0.9999 (n=5), the average recovery was 99.93%, RSD=1.19%(n=9). Conclusions this method is simple, accurate and reliable, and can be used to control the quality of compound cyclophosphamide capsules. ......
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