Simultaneous estimation of gemcitabine hydrochloride and capecitabine hydrochloride in combined tablet dosage form by RP-HPLC method

Abstract

A new reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the simultaneous estimation of gemcitabine hydrochloride and capecitabine hydrochloride in combined tablet dosage form. An inertsil ODS-3 C-18 column having dimensions of 250 × 4.6 mm and particle size of 5 μm, with mobile phase containing a mixture of acetonitrile : water : triethyelamine in the ratio of (70 : 28 : 2v/v) was used. The pH of mobile phase was adjusted to 4.0 with ortho-phosphoric acid. The flow rate was 1 mL/min and the column effluents were monitored at 260 nm. The retention time for gemcitabine hydrochloride and capecitabine hydrochloride was found to be 2.76 and 2.3 min respectively. The proposed method was validated in terms of linearity, accuracy, precision, limit of detection, limit of quantitation and robustness. The method was found to be linear in the range of 10-50 μg/mL and 4-24 μg/mL for gemcitabine hydrochloride and capecitabine hydrochloride, with regression coefficient = 0.999 and r = 0.999, respectively.