Turner Emily A, Stenson Alexandra C, Yazdani Saami K
Department of Mechanical Engineering, University of South Alabama, Mobile, AL 36688, USA.
Department of Chemistry, University of South Alabama, Mobile, AL 36688, USA.
J Pharm Biomed Anal. 2017 May 30;139:247-251. doi: 10.1016/j.jpba.2017.03.011. Epub 2017 Mar 10.
Local drug delivery of paclitaxel is becoming ever more prevalent. As complex drug/excipient combinations are being developed and tested, new high performance liquid chromatography-mass spectrometry (HPLC-MS) techniques capable of quantifying paclitaxel from such formulations are needed. Here a method for quantifying paclitaxel from aqueous, protein and oil containing samples was developed and validated. Keratin, derived from human hair, is the protein component/paclitaxel excipient in the development and validation of said method. The novelty of this method is described by its ability to overcome water solubility issues and address clean-up of residual solvents in clinical grade paclitaxel injection composition. The method evaluates tert-butyl methyl ether and ethanol as extraction solvents with an extraction efficiency of 31.9±2.3% and 86.4±4.5% respectively. Upon evaporation and rehydration, samples were evaluated by HPLC-MS and a method was developed for paclitaxel quantification. The method developed had an inter-day precision of 9.1% relative standard deviation and an intra-day precision of 4.3% relative standard deviation normalized to a docetaxel internal standard. The described method is applicable to any aqueous paclitaxel sample containing protein and/or oils.
紫杉醇的局部给药正变得越来越普遍。随着复杂的药物/辅料组合的开发和测试，需要能够从此类制剂中定量分析紫杉醇的新型高效液相色谱-质谱（HPLC-MS）技术。在此，开发并验证了一种从含水性、蛋白质和油类的样品中定量分析紫杉醇的方法。来源于人发的角蛋白是所述方法开发和验证过程中的蛋白质成分/紫杉醇辅料。该方法的新颖之处在于其能够克服水溶性问题，并解决临床级紫杉醇注射剂组合物中残留溶剂的净化问题。该方法评估了叔丁基甲基醚和乙醇作为萃取溶剂，萃取效率分别为31.9±2.3%和86.4±4.5%。蒸发和复水后，通过HPLC-MS对样品进行评估，并开发了一种紫杉醇定量方法。所开发的方法相对于多西他赛内标，日间精密度的相对标准偏差为9.1%，日内精密度的相对标准偏差为4.3%。所述方法适用于任何含蛋白质和/或油类的水性紫杉醇样品。
