Development and Validation of a New Stability Indicating RP-UFLC Method for the Estimation of Imatinib Tablets Using an Ion Pairing Agent
Bandaru Sai Pavan Kumar and Mukthinuthalapati Mathrusri Annapurna*
Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management, Visakhapatnam, India
*Corresponding Author: Mukthinuthalapati Mathrusri Annapurna, Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management, Visakhapatnam, India.
October 19, 2022; Published: November 30, 2022
Imatinib is a tyrokinase inhibitor used for the treatment of cancer. A new stability indicating RP-UFLC method has been developed and validated for the determination of Imatinib using an ion pairing agent, tetra butyl ammonium hydrogen sulphate in combination with methanol (45: 55) with flow rate 1.0 mL/min and PDA detection at 281 nm. Imatinib shows linearity over the concentration range 0.05-80 mg/ml and the linear regression equation is found to be y = 62542x + 9790.6 with correlation coefficient 0.9999. The LOD and LOQ were found to be 0.0138 mg/ml and 0.0418 mg/ml respectively. Imatinib was exposed to different stress conditions and results indicate that the method is specific and selective and the method was applied for the pharmaceutical formulations such as Imatinib tablets and was validated as per ICH guidelines.
Keywords: Imatinib; RP-UFLC; Stability Indicating; Validation; ICH Guidelines
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