Analytical Method Validation Of Sulfamethoxazole By UV-Spectroscopy

Abstract

For the quantitative determination of Sulfamethoxazole 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) guideline.  The highest absorption wavelength of a spiked Sulfamethoxazole solution was measured over the UV-Visible spectrum. The absorbance was measured at the wavelength of maximum absorbance using several calibration standards of Sulfamethoxazole. 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 maximal wavelength of Sulfamethoxazole was 262 nm with 0.1N NaOH with a regression coefficient of 0.999, the substance followed Beer's Law in the concentration range of 2–10μg/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 of 0.93 to 1.38 respectively, which is < 2%. The % assay for sulfamethoxazole in formulation was found to be 99.5. According to ICH (International Conference on Harmonization) standards, the analyses' findings have been validated.