Gefitinib is an anticancer drug used for the treatment of lung cancer, breast cancer and prostate cancer. A new stability indicating RP-HPLC method was proposed for the estimation of Gefitinib in pharmaceutical dosage forms (tablets). Shimadzu Model CBM-20A/20 Alite HPLC system with PDA detector and Agilent C18 column were used for the chromatographic study. Mobile phase mixture consisting of Tetra butyl ammonium hydrogen sulphate and Methanol in the ratio 50:50, v/v with a flow rate 0.8 mL/min was chosen for the chromatographic elution of Gefitinib (Detection wavelength 340 nm). The method was linear over the concentration range 0.1-80 mg/mL with linear regression equation, y = 70782x + 6171.6 (R² = 0.9999). The LOD and LOQ were found to be 0.2931 mg/mL and 0.8947 mg/mL respectively. Stress degradation studies were performed by exposing Gefitinib to various stress conditions and the method was validated as per ICH guidelines.
Cite this article:
Sai Gnaneswari Aluri, Mukthinuthalapati Mathrusri Annapurna. A New stability indicating RP-HPLC method for the estimation of Gefitinib tablets using an ion pairing agent. Research Journal of Pharmacy and Technology 2021; 14(10):5449-6. doi: 10.52711/0974-360X.2021.00950
Sai Gnaneswari Aluri, Mukthinuthalapati Mathrusri Annapurna. A New stability indicating RP-HPLC method for the estimation of Gefitinib tablets using an ion pairing agent. Research Journal of Pharmacy and Technology 2021; 14(10):5449-6. doi: 10.52711/0974-360X.2021.00950 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-10-68
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