超高效液相色谱法测定紫杉肽中紫杉醇含量  

UHPLC determination of paclitaxel in polydipeptide paclitaxel

作　　者：李京峰[1,2] 孟志云[2] 朱晓霞[2] 甘慧[2] 顾若兰[2] 吴卓娜[2] 窦桂芳[1,2] 

机构地区：[1]广西医科大学,南宁530021 [2]军事医学科学院野战输血研究所,北京100850

出　　处：《国际药学研究杂志》2014年第6期703-706,共4页Journal of International Pharmaceutical Research

摘　　要：目的建立超高效液相色谱法（UHPLC）测定聚二肽紫杉醇（紫杉肽）注射制剂中紫杉醇含量。方法紫杉肽注射制剂以蒸馏水溶解，经2.0 mol/L氢氧化钠溶液降解处理后，通过对紫杉醇降解产物的测定，间接标定紫杉肽注射制剂中紫杉醇的含量。采用Agilent SB C18（2.1 mm ×50 mm，1.8μm）色谱柱，流动相为乙腈-水（10∶90，V/V），流速0.2 ml/min，检测波长240 nm（参比波长360 nm），柱温40℃（±0.5℃），自动进样器温度15℃（±0.5℃），进样体积2μl。结果紫杉醇浓度在0.31～5.00 mg/ml范围内与其降解产物的峰面积呈现良好的线性关系（r=0.9992，n=5）。不同批次紫杉肽注射制剂中每支含紫杉醇的量在26.77～33.19 mg范围内。结论本方法准确、快速，重现性好，适用于紫杉肽注射制剂中紫杉醇含量分析。Objective To establish an ultra-high-performance liquid chromatograph（UHPLC）method for the determination of paclitaxel （PTX）in polydipeptide paclitaxel （PDP）preparation. Methods PDP preparation was dissolved in deionized water （DIW） and degraded by 2.0 mol/L sodium hydroxide solution. The concentration of paclitaxel was calculated indirectly by its degradation product. The separation was achieved on an Agilent SB C18 column（2.1 mm × 50 mm,1.8μm）. Elution was carried out using a mobile phase consisting of acetonitrile-water （10 ∶ 90,V/V）at the flow rate of 0.2 ml/min. UV detection wavelength was performed at 240 nm and reference wavelength was 360 nm. The temperatures of autosampler and column were thermostated at 15℃（± 0.5℃）and 40℃（± 0.5℃）,respectively. The injection volume was 2 μl. Results The relationship between the concentration of paclitaxel （0.31-5.00 mg/ml）and the peak area of its degradation product was in good linearity （r=0.9992,n=5）. Total amount of paclitaxel in different batches of PDP preparation was in the range of 26.77-33.19 mg per vial. Conclusion The method is accurate, rapid,reproducible and suitable for the analysis of paclitaxel in PDP preparation.

关 键 词：紫杉醇 紫杉肽 含量测定 超高效液相色谱法 

分 类 号：R286.0[医药卫生—中药学] O657.72[医药卫生—中医学]