a Department of Pharmaceutical Quality Assurance, Krishna School of Pharmacy & Research, Drs. Kiran & Pallavi Patel Global University, Krishna Edu Campus, Vadodara – Mumbai National Highway # 8, Varnama, Vadodara- 391 243, Gujarat, India
b Department of Pharmaceutical Quality Assurance, Babaria Institute of Pharmacy, BITS Edu Campus, Vadodara – Mumbai National Highway # 8, Varnama, Vadodara- 391 243, Gujarat, India
* For Correspondence: E-mail: shaileshkoradia.ksp@kpgu.ac.in
https://doi.org/10.53879/id.59.12.13081
ABSTRACT
In the present research work, a simple, accurate and precise spectrophotometric method has been developed for the determination of gefitinib in bulk and its tablets dosage form. Gefitinib was dissolved in 0.1 N hydrochloric acid and absorbance was measured at 252.0 nm. The calibration curve obeyed Beer’s law in the concentration range of 3-15 µg mL-1 with correlation co-efficient of 0.9989. The detection limits and quantitation limits were found to be 0.69 µg mL-1 and 2.08 µg mL-1, respectively. The recovery ranged between 98.00 and 101.89 %. The validation parameters such as accuracy, precision, linearity, limit of detection and limit of quantitation of developed method were validated according to international conference on harmonization (ICH) Q2-R1 guidelines and successfully analyzed gefitinib from tablet dosage form.