中国药房2013，Vol.24Issue(11)：1020-1022,3.DOI:10.6039/j.issn.1001-0408.2013.11.22
不同厂家紫杉醇注射液的稳定性考察
Stability of Paclitaxel Injection from Different Manufacturers
摘要
Abstract
OBJECTIVE: To investigate the stability of Paclitaxel injection from different manufacturers, and to provide evidence for safe and effective drug use in the clinic. METHODS: HPLC method was adopted to determine the content of Paclitaxel injection and impurity. The determination was performed on Kromasil-C18(250 mm×4.6 mm,5μm) column with mobile phase consisted of ethanol-water-acetone (23 :41:36, V/V/V) at flow rate of 1.0 ml/min. The detection wavelength was set at 227 run and column temperature was room temperature. RESULTS: The appearance of samples was in line with the standard; pH value was between 5.83-7.22; the linear ranges of paclitaxel were 10-120 μg/ml(r=0.999 9) with an average recovery of 100.59%(RSD = 1.05%,n= 6); the sample solution was stable within 8 h. CONCLUSION: The appearance, pH value, content and microparticle of Paclitaxel injection from different manufacturers consistent with the standard.关键词
紫杉醇注射液/稳定性/高效液相色谱法/微粒/含量测定Key words
Paclitaxel injection/ Stability/ HPLC/ Microparticle/ Content determination分类
医药卫生引用本文复制引用
李雅静,王晨,王淑静..不同厂家紫杉醇注射液的稳定性考察[J].中国药房,2013,24(11):1020-1022,3.
