Simple and Sensitive Spectrophotometric Methods for Estimation of Vortioxetine HBr in Pharmaceutical Formulations | ||||
| Bulletin of Faculty of Science, Zagazig University | ||||
| Article 5, Volume 2025, Issue 3, July 2025, Page 52-63 PDF (851.26 K) | ||||
| Document Type: Original Article | ||||
| DOI: 10.21608/bfszu.2024.332747.1439 | ||||
 View on SCiNiTO | ||||
| Authors | ||||
Ayman A Gouda  1; Ragaa elsheikh2; Noha E.M. Elsaify3; Nehal S.A. Soliman3; Asmaa El Sayed2; Ahmed Salah Eldien2; Asmaa S Abdelhamed2; Mohamed A. Afify2
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| 1Chemistry Department, Faculty of Science, Zagazig University, Zagazig, Egypt | ||||
| 2Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt. | ||||
| 3Department of Chemistry, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt. | ||||
| Abstract | ||||
| A precise, user-friendly, sensitive, and validated spectrophotometric method has been developed for the quantification of vortioxetine HBr (VOR) in both pure and dosage forms. This method utilized N-bromosuccinimide (NBS) as a sustainable oxidizing agent in conjunction with three selected dyes: amaranth (AM), methylene blue (MB), and indigocarmine (IC). The methods employ excess amounts of NBS in acidic conditions to oxidize vortioxetine HBr. The unreacted NBS is quantitatively analyzed using predetermined quantities of the dyes AM, MB, and IC. Absorption was measured at 520 nm, 663 nm, and 609 nm for AM, MB, and IC dyes, respectively. The analytical technique was performed and validated through a thorough analysis and optimization of many factors that could potentially disrupt the reaction. Under optimal conditions, significant linear correlations were observed, with correlation coefficients ranging from 0.9993 to 0.9996. The associations were applicable within concentration ranges of 1.0-15, 0.5-12, and 0.50-10 µg/ml, respectively. The LOD values recorded were 0.30, 0.15, and 0.15 μg/ml, but the LOQ values were determined to be 1.0, 0.50, and 0.50 μg/ml for the AM, MB, and IC methods, respectively. The validated methods for analyzing vortioxetine HBr in dosage forms exhibited great accuracy and precision. The approaches' dependability was validated using recovery studies employing the standard addition method. The statistical analysis comparing results from the proposed approaches with those from the established approach, employing Student's t-test and variance ratio F-test at a 95% confidence level, revealed substantial agreement and indicated no significant differences in accuracy and precision. | ||||
| Keywords | ||||
| Vortioxetine HBr; N-bromosuccinimide; Spectrophotometry; Method of validation; Pharmaceutical Formulations | ||||
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