Abstract

A NOVEL ULTRAVIOLET-VISIBLE SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF CARBAMAZEPINE IN BULK DRUG AND ITS FORMULATION

P. Pravalika* and L. Madhuri

ABSTRACT

For the quantitative determination of carbamazepine in a pharmaceutical formulation, a new straightforward, accurate, quick, precise, reproducible, and cost-effective spectrophotometric approach has been developed and validated in accordance with the ICHQ2 (R1) guidelines. The highest absorption wavelength of carbamazepine solution was measured over the UV-Visible spectrum. The absorbance was measured at the wavelength of maximum absorbance using several calibration standards of carbamazepine. Calculations were made to determine the linearity and range of the calibration curve of concentration vs. absorbance. QC standards were validated, including accuracy, precision, LOD, LOQ, and robustness. It was found that the maximum wavelength of carbamazepine was 285 nm with 0.1N NaOH
with a regression coefficient of 0.999, the substance followed Beer's Law in the concentration range of 2–10 μg/ml. The % recovery was found to be between 99.2 and 100.8%, demonstrating that the developed method was accurate. The method's reproducibility was indicated by less % RSD. The % RSD for intra-day and inter-day precision was determined to be less than 2%. The % assay for carbamazepine in formulation was found to be 99.5. According to ICH (International Conference on Harmonization) standards, the analyses' findings have been validated.

Keywords: UV-Visible spectrometry, Carbamazepine, Validation, Linearity, Anti seizures.