【摘要】 目的考察多西紫杉醇注射液在不同条件下的稳定性。方法系统考察不同条件下本品的稳定性,条件分别为高温(40℃)4、500 lx强光试验考察10 d,室温(25℃)和低温(4℃)试验各考察3 mo。建立一个简单的HPLC法用于稳定性试验中多西紫杉醇和降解产物的含量测定。色谱条件为:色谱柱Alltima C18柱(150 mm×4.6 mm,5μm),以甲醇∶20 mmol.L-1醋酸钠缓冲液(pH 5.0)(74∶26)为流动相,流速1.0 mL.min-1,检测波长232 nm。结果除低温避光条件外,多西紫杉醇注射液含量均有明显下降。建立的HPLC法在25~500 mg.L-1时线性方程为y=7.009×10-4x+1.027 6(r=0.999 8),日内、日间RSD均<6%。结论多西紫杉醇注射液贮放条件应为低温避光。更多还原

【Abstract】 AIM To determine the stability of docetaxel injection under various storage conditions.METHODS Samples of docetaxel injections were put under different conditions(4℃,25℃,40℃ and strong light of 4 500 lx) to determine the content of docetaxel and its degradation products by a simple HPLC method.HPLC analyses were performed by using an Alltima C18 column (150 mm×4.6 mm,5 μm)and UV detector at 232 nm wavelength.The mobile phase consisted of methanol∶20 mmol·L-1 sodium acetate(pH 5.0)(74∶26,V/V)with the flow rate of 1.0 mL·min-1.RESULTS The content of docetaxel decreased remarkably under all the experimental conditions except for 4℃ without light.The calibration curve was linear within the range of 25-500 mg·L-1 with the calibration equation y=7.009×10-4x+1.027 6(r=0.999 8).Both the intra-and inter-RSD were <6%.CONCLUSION After thorough investigation of the storing conditions that affect the stability of docetaxel injections,it is suggested that docetaxel injection should be stored at 4℃ without light.更多还原