@article{article_1161168, title={Alternative Analytical Methods for Quantification of Galantamine in Pharmaceuticals}, journal={Ege Tıp Bilimleri Dergisi}, volume={5}, pages={58–64}, year={2022}, DOI={10.33713/egetbd.1161168}, author={Taşpınar, Numan and Bulduk, İbrahim}, keywords={Galantamin, HPLC, UV, Yöntem, Validasyon}, abstract={<p> <b>Objective: </b>For the quantification of galantamine in bulk and pharmaceutical dosage form, new selective, quick, precise, and accurate spectrophotometric and chromatographic procedures were developed and validated. </p> <p> <b>Material & Methods: </b> Chromatographic separation was performed on an Agilent Extend C18 (250×4.6 mm, 5 µm) column. Ultrapure water containing 0.1% TFA and acetonitrile containing 0.1% TFA (85/15, v/v) were used as mobile phase at a flow rate of 1.0 mL/min. Eluent detection was performed at a wavelength of 288 nm using a UV detector. On the other hand, galantamine was determined by spectrophotometric technique by measuring the absorbance of the solutions at a wavelength of 288 nm. </p> <p> <b>Result: </b>Lambert−Beer plots for galantamine showed linear relationships in the concentration range of 5-30 μg/mL. Both techniques have been statistically evaluated and validated in order to meet the standards of the International Conference on Harmonisation (ICH) and the results showed that spectrophotometric and liquid chromatographic methods were linear, precise, accurate, rugged and robust with RSD values less than 1.00%, and the recovery percentage was within standard limits (98-102%). Then a statistical comparison of these analytical methods was performed. The results of both methods showed no difference and not statistically significant with respect to each other in the 95% confidence interval (p<0.05). </p> <p> <b>Conclusion: </b>The developed analytical methods were determined to be accurate, highly effective, reliable, fast, simple, and may be employed successfully for routine analysis of galantamine in the bulk as well as pharmaceutical dosage form. They may even be used for quality control analysis and for sample analysis during cleaning validation. </p>}, number={2}, publisher={Uşak Cerrahi Derneği}