Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GEFITINIB TABLETS BY RP-HPLC & QUALITATIVE ANALYSIS OF TAZOBACTAM BY USING DIFFERENT ANALYTICAL TECHNIQUES

Konety Prabhakar, K. Thejomoorthy*, Ch Saibabu

ABSTRACT

The aim of the present work was to develop and validate a simple, efficient, economical method for the estimation of Gefitinib and in bulk and dosage forms by high pressure liquid chromatography. Chromatography was performed on with Agilent TC-C18 (2) 5 m 4.6250 mm, mobile phase containing Mobile phase – Acetonitrile, Methanol and Tetrahydrofuran (20:70:10) at a flow rate of 1 mL/min and eluents were monitored at 249 nm. The retention time of Gefitinib was 10.00 min showed a good linearity in the concentration range of 0.5-2.5 μg/mL for Gefitinib with a correlation coefficient of 0.997. The validation characteristics included specificity, linearity, and limit of detection, limit of quantification, precision, robustness and stability. Validation acceptance criteria were met in all cases. The percent recoveries ranged between 85-115%, RSD < 2%. The method could be successfully used for the analysis of Gefitinib in bulk and dosageforms.

Keywords: RP- HPLC, Gefitinib, Validation, Dosage forms.