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METHOD DEVELOPMENT AND VALIDATION GEMCITABINE AND CARBOPLATIN IN BULK AND IN ITS PHARMACEUTICAL DOSAGE FORMS USING HPLC AS PER ICH GUIDELINES
A new method was established for simultaneous estimation of Gemcitabine and Carboplatin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Gemcitabine and Carboplatin by using Inertsil ODS C18 5µm (4.6 x 250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M, pH 4.6) and Acetonitrile in the ratio 55:45%v/v and pH was adjusted with Orthophosphoric acid, detection wave length was 274 nm. The analytical method was validated according to ICH guidelines. The linearity study for Gemcitabine and Carboplatin was found in concentration range of 1μg-5μg and100μg-500μg and correlation coefficient was found to be 0.999 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was 0.2 and 0.4, % RSD for intermediate precision was 0.5 and 0.1 respectively.
KEYWORDS: Gemcitabine, Carboplatin, Inertsil ODS and RP-HPLC.