Stability Indicating Analytical Method Development And Validation Of Carbamazepine Using UV Spectroscopy

A novel Spectrophotometric method for quantifying carbamazepine in pharmaceuticals has been developed and validated per ICH Q2 (R1) guidelines. The maximum absorption wavelength was identified at 285 nm in a 0.1N NaOH solution, with a regression coefficient of 0.999, confirming adherence to Beer's Law within a 2–10 μg/ml concentration range. Calibration curves demonstrated linearity, and quality control standards showed accuracy, precision, and robustness, with recovery percentages between 99.2% and 100.8%. The method exhibited low relative standard deviation (RSD) values, with intra-day and inter-day precision RSDs of 0.93% to 1.38%. The assay result for carbamazepine in the formulation was 99.5%, validating the method according to ICH standards.