ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GEMCITABINE AND CLARITHROMYCIN IN COMBINED DOSAGE FORM BY RP-HPLC METHOD

A reverse phase high performance liquid chromatographic method was developed for simultaneous estimation of gemcitabine and clarithromycin in bulk and tablet dosage form. The method was developed by using acetonitrile: methanol: 50 mM sodium acetate buffer (adjusted to pH-3 with orthophosphoric acid (40:40:20) as a mobile phase at the flow rate of 1mL/min. The retention time was found to be 2.365 and 5.999 minutes, respectively. The method showed linearity in the concentration range 10-50 µg/mL in respect of both drugs. The % RSD was less than 0.4% for gemcitabine and 0.2% for clarithromycin. Mean percentage recovery was found to be 99.63 and 99.69 for gemcitabine and clarithromycin. The tailing factor for gemcitabine and clarithromycin was not less than 0.9 and not more than 1.4 during the robustness study. The average percentage assay was calculated and found to be 99.83 for gemcitabine and 98.89 for charithromycin. The limit of detection and quantification for gemcitabine was found to be 0.41 and 1.79 µg/mL. For Clarithromycin, the value was 0.58 and 1.37 µg/mL respectively.