European Journal of Biomedical and Pharmaceutical Sciences

UPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF GEFITINIB IN API AND MARKETED PHARMACEUTICAL DOSAGE FORM

Kandhagatla Saisneha*, Pragathi Talusani, Rajani Lagisetty and Valluri Naga Sravani

ABSTRACT

An analytical, accurate, precise, specific, efficient and simple Ultra-Performance Liquid Chromatography method has been developed and validated for the determination of Gefitinib in bulk and was applied on marketed Pharmaceutical Dosage form. The mobile phase used for the chromatographic runs consisted of 0.1% OPA Buffer and Acetonitrile in the ratio of 35:65% v/v. The separation was achieved on a BHEL UPLC column using isocratic mode. Gefitinib Drug peak were well separated and were detected by a PDA detector at 254 nm. The developed method was linear at the concentration range 6–14 μg/ml for Gefitinib. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. The LOD and LOQ for the Gefitinib were found to be 0.5853 μg/ml and 1.7738μg/ml respectively. The developed method is simple, precise, specific, accurate and rapid, making it suitable for estimation of Gefitinib in bulk and marketed pharmaceutical dosage form dosage form.

Keywords: Gefitinib, UPLC, Accuracy, Precision, Robustness, ICH Guidelines.