Abstract

A simple, accurate, specific and rapid stability indicating RP-HPLC method was developed for the simultaneous estimation of Gemcitabine and Clarithromycin in combined dosage form. A Novapack symmetry, C18, 150mm x3.9mm, 5μ column was used for the complete separation of the drugs. A mixture of potassium dihydrogenorthophosphate and dipotassium hydrogen orthophosphate in dilute phosphoric acid at a pH of 3.5 was used as buffer solution and a 55:45 ratio mixture of buffer and acetonitrile was used as mobile phase ( diluent ) .The chromatograms were taken at a flow rate of 1.0 mL/min, temperature of 300 C and detection wave length of 212 nm with isocratic elusion . The retention time for Gemcitabine standard (sample) was 2.373 min and for Clarithromycin standard (sample) was 5.995min respectively. The linearity range for Gemcitabine was 18.75 -112.50 μg/mL and for Clarithromycin 12.5 -75 μg/mL The recovery of Gemcitabine was in the range 99.86 – 99.95 % and for Clarithromycin 99.94 – 99.97 %. Gemcitabine degraded from 15.45% to 37.01% and Clarithromycin degraded from 9.51% to 37.46% under varied stress conditions. The present stability indicating RP-HPLC method can be used for the accurate, precise, and rapid simultaneous determination of Gemcitabine and Clarithromycin in the combined dosage form. No co eluting peaks were obsereved with main peaks and the method is specific for the estimation of both the drugs in presence of their degradation products.