Stability Indicating Analytical Method Development And Validation Of Carbamazepine Using UV Spectroscopy
Year: 2024
Type: article
Abstract: 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.
Author: Banothu Bhadru*, Tadikonda Rama Rao, Arukala Bhavani
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W6893017264
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