Development and Validation of RP-HPLC Method: Scope of Application in the Determination of Oil Solubility of Paclitaxel
Development and Validation of RP-HPLC Method: Scope of Application in the Determination of Oil Solubility of Paclitaxel
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DOI：
10.1093/chromsci/bms206
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发表时间：
2014-01-01
影响因子：
1.3
通讯作者：
Pal, Tapan Kumar
中科院分区：
文献类型：
--
作者：
Choudhury, Hira;Gorain, Bapi;Pal, Tapan Kumar
建立了一种简便、重现性好、可行、创新的反相高效液相色谱法，并验证了该方法的有效性。从capryol 90、三醋精和橄榄油中提取分析物后，对该方法进行了验证。该方法在Hypersil BDS C18色谱柱（250 x 4.6 mm，5 μ m粒径）上进行，移动的流动相由乙腈：10 mM KH 2 PO 4缓冲液（pH 3.5）（55：45，v/v）组成，检测波长为227 nm。在5 - 50 μ g/mL范围内，线性显示辛酸90、三醋精和橄榄油中的决定系数分别为0.9983、0.9997和0.9990（通过最小二乘回归法计算）。对于辛酸90、三醋精和橄榄油，回收率百分比的日内精密度值分别为0.68 - 0.80、0.83 - 1.13和0.97 - 1.88，日间精密度值分别为1.52 - 1.92、1.43 - 1.83和1.26 - 2.06。紫杉醇从辛酸90、三醋精和橄榄油中的回收率分别为97.94 - 103.55%、96.85 - 103.27%和97.14 - 103.64%。这种开发和验证的方法已成功应用于定量评估紫杉醇溶解在各种油。发现紫杉醇在三醋精中的溶解度高于在其他测试油中的溶解度。
A simple, reproducible, feasible and innovative reversed-phase high-performance liquid chromatographic method was developed and validated for the quantitative determination of paclitaxel dissolved in various oils. The method was validated after extraction of the analyte from capryol 90, triacetin and olive oil. The method was conducted on a Hypersil BDS C18 column, 250 x 4.6 mm, 5 mu m particle size, with a mobile phase composed of acetonitrile: 10 mM KH2PO4 buffer (pH 3.5) (55: 45, v/v) and detection at 227 nm. The linearity, in the range of 5 to 50 mu g/mL, presented determination coefficients of 0.9983, 0.9997 and 0.9990 in capryol 90, triacetin and olive oil, respectively, calculated by the least-squares regression method. Intra-day precision values for percentages recovered were 0.68 to 0.80, 0.83 to 1.13 and 0.97 to 1.88, and inter day precision values were 1.52 to 1.92, 1.43 to 1.83 and 1.26 to 2.06 for capryol 90, triacetin and olive oil, respectively. The recovery of paclitaxel from the capryol 90, triacetin and olive oil ranged from 97.94 to 103.55, 96.85 to 103.27 and 97.14 to 103.64%, respectively. This developed and validated method was successfully applied to quantitatively assess paclitaxel dissolved in various oils. The solubility of paclitaxel was found to be higher in triacetin than in other tested oils.