Stability indicating RP-HPLC method development for docetaxel trihydrate

Abstract

The purpose of present study was to develop RP-HPLC method for estimation of docetaxel trihydrate which should be a suitable, simple, precise, accurate, robust, and reproducible. The samples were assayed by the Shimadzu HPLC instrument - LC-20AD (Japan) equipped with Shimadzu SPD-M20A UV-VIS detector operated at wavelength of 230 nm. The binary gradiant pump was used for the analytical method development. The reverse phase stainless steel column (150 × 4.6 mm) packed with 5 μm particles (C-8, LiCrosphore® 100, Germany) was used to take chromatograph. A mobile phase consisting of acetonitrile/phosphate buffer 20 mM, (45:55, v/v), pH 3.5 adjusted with o-phosphoric acid at a flow rate of 1 mL/min. The method was validated by system suitability and reproducibility. The linearity was also determined using samples with five different concentrations of 20, 40, 60, 80 and 100 µg/mL. The results of the study showed that the developed RP-HPLC method is simple and robust which is useful for the estimation of docetaxel trihydrate in bulk drug and in pharmaceutical dosage form. The results of stability show that the method has stability over a period of 48 h at room temperature. Keyword: Docetxel trihydrate, RP-HPLC method, validation, stability