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1 2016

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Macromolecular conjugates of paclitaxel: Synthesis, characterization, and In Vitro paclitaxel release studies based on HPLC validated method

Stefanowicz Z., Sobczak M., Piętniewicz A., Kołodziejski W. L.

Acta Chromatographica

2016

Vol. 28, no. 1

99--117

Biodegradable and bioresorbable macromolecular conjugates of paclitaxel were prepared. The release of drug from conjugates has been carried out in vitro at 37 °C in phosphate buffered saline solution (PBS, pH 7.4), with 0.1% (w/v) Cremophor® EL. Periodically, all the solution in the samples was removed and replaced with fresh buffer until limit of detection (LOD) of paclitaxel was released. The quantity of released drug was analyzed by means of high-performance liquid chromatography (HPLC) method. Chromatographic separations were conducted using the NUCLEODUR C18 Gravity column with a guard column at 30 °C. Mobile phase consisted of a mixture of acetonitrile, methanol, and deionized water (60:2:38). The flow rate was 1.0 mL min -1, and paclitaxel was detected at 229 nm, retention time of 3.5 min. The applied analytical method was validated according to International Conference on Harmonization (ICH) procedures or recommendations. The chromatographic separation was excellent. The linearity in the range 0.1–4.5 μg Ml -1 was found to be very good (R2 = 0.9999). LOD and limit of quantification (LOQ) were calculated to be 0.023 μg Ml -1 and 0.068 μg Ml -1, respectively. The release profiles were evaluated and compared. The process of paclitaxel release from Paclcon-2 conjugate seems to be the most interesting. Paclitaxel is released the longest and the most evenly.