Spectrophotometric Methods for Quantitative Determination of Imeglimin HCl in Pure and Dosage Forms | ||
| Bulletin of Faculty of Science, Zagazig University | ||
| Article 17, Volume 2024, Issue 4, January 2025, Pages 190-200 PDF (1.21 M) | ||
| Document Type: Original Article | ||
| DOI: 10.21608/bfszu.2024.269102.1364 | ||
| Authors | ||
| Ayman A Gouda* 1; Alaa S. Amin2; Soha Fahium3; Abd El Moamen R.M. Mahdy4; Noha E.M. Elsaify4; Nehal S.A. Soliman4 | ||
| 1Chemistry Department, Faculty of Science, Zagazig University, Zagazig, Egypt | ||
| 2Chemistry Department, Faculty of Science, Benha University, Benha, Egypt. | ||
| 3chemistry department, zagazig univeristy | ||
| 4Department of Chemistry, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt. | ||
| Abstract | ||
| Simple, precise, reproducible, and validated spectrophotometric methods have been developed for the determination of imeglimin hydrochloride (IMGH) in pure and dosage forms. The methods are based on the formation of a yellow-colored ion-pair complex between IMGH and three reagents, namely, alizarine red s (ARS), bromophenol blue (BPB), and methyl orange (MO), in an acidic buffer solution with absorption maxima at 410, 420, and 420 nm, respectively. Several parameters, such as pH, buffer type and volume, reagent volume, sequence of addition, and effect of extracting solvent, were optimised. Under the optimum experimental conditions, Beer’s law is obeyed over the concentration ranges of 1.0–20 μg/ml for the three reagents, with good correlation coefficients (0.99985-0.99988). The apparent molar absorptivity's and Sandell’s sensitivity values are reported for all methods. The limit of detection (LOD) and the limit of quantification (LOQ) values are found to be 0.28, 0.30, and 0.31 μg/ml and 0.86, 0.93, and 0.97 μg/ml for ARS, BPB, and MO, respectively. The stoichiometric ratio of the formed ion-pair complexes was found to be 1:1 (drug: reagent) for all methods, as deduced by Job's method of continuous variation. The proposed methods were successfully applied for the determination of IMGH in dosage forms with good accuracy and precision. A statistical comparison of the results was performed using the Student's t-test and variance ratio F-test at the 95% confidence level, and there was no significant difference between the reported and proposed methods regarding accuracy and precision. Fu | ||
| Keywords | ||
| Imeglimin hydrochloride; Ion-pair complex; Spectrophotometry; Method validation; Dosage forms | ||
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