Development and Validation of Green and High-Throughput Microwell Spectrophotometric Assay for the Determination of Selective Serotonin Reuptake Inhibitors in Their Pharmaceutical Dosage Forms

Abstract

This study describes the development and validation of a new green and high-throughput microwell spectrophotometric assay (MW-SPA) for the determination of three selective serotonin reuptake inhibitors (SSRIs) in their pharmaceutical dosage forms. These SSRIs are fluoxetine, fluvoxamine, and paroxetine, the most prescribed drugs for the treatment of depression. The proposed assay was based on the formation of orange-colored N-substituted naphthoquinone derivatives upon the reaction of SSRIs with 1,2-naphthoquinone-4-sulphonate (NQS) in alkaline media. The assay was conducted in 96-microwell assay plates, and the absorbances of the reaction products were measured by a microplate reader at their maximum absorbance wavelengths. The optimum conditions of the reaction were refined and established. Under these conditions, calibration curves were generated, and linear regression equations were computed. The linear relations between the absorbances and drug concentrations were linear with good correlation coefficients (0.9992–0.9997) in the range of 2–80 µg/mL. The assay limits of detection were in the range of 1.5–4.2 µg/mL. The precision was satisfactory as the values of relative standard deviation did not exceed 1.70%. The accuracy of the assay was ≥98.2%. The proposed MW-SPA was successfully applied to the analysis of the SSRIs in their pharmaceutical dosage forms with acceptable accuracy and precision; the label claims were 99.2–100.5% (±0.96–1.35%). The results of the proposed MW-SPA were compared with those of the official/pre-validated assays by statistical analysis with respect to the accuracy (by t-test) and precision (by F-test). No significant differences were found between the calculated and theoretical values of the t- and F-tests at the 95% confidence level, proving similar accuracy and precision in the determination of SSRIs by both assays. The greenness of the proposed assay was confirmed by two metric tools. In addition, the assay is characterized with a high-throughput property which enables the simultaneous analysis of many samples in a short time. Therefore, the assay is a valuable tool for rapid routine application in pharmaceutical quality control units for the determination of the investigated SSRIs.

Spectrophotometric Study of Charge-Transfer Complexes of Ruxolitinib with Chloranilic Acid and 2,3-Dichloro-5,6-dicyano-1,4-benzoquinone: An Application to the Development of a Green and High-Throughput Microwell Method for Quantification of Ruxolitinib in Its Pharmaceutical Formulations

“…Considering the advantages of microwell-based analysis [20][21][22][23][24][25], the methodology was considered for this study. The formation of CTCs plays a crucial role in various scientific disciplines, including spectrophotometry-based pharmaceutical analysis [28][29][30][31].…”

“…Moreover, by employing microscale techniques, the amount of hazardous chemicals/solvents used in the laboratory can be decreased, contributing to enhanced sustainability [22,23]. The versatility of this technique allows for various applications in the pharmaceutical industry [24][25][26]. Microwell spectrophotometry lends itself well to automation using robotic systems, leading to improved efficiency, reduced errors, and time and labor savings in the laboratory.…”

Development of Two Novel One-Step and Green Microwell Spectrophotometric Methods for High-Throughput Determination of Ceritinib, a Potent Drug for Treatment of Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer

“…This methodology has emerged as a valuable tool in the pharmaceutical analysis field due to its ability to meet the requirements of green chemistry approaches [25][26][27] and high-throughput analysis [28,29]. The methodology provides a combination of many advantages, such as miniaturization, automation, and parallelization, achieving significant advancements in both environmental sustainability and efficient analysis of large sample sets [30][31][32]. Microwell analyses contribute to green chemistry in several ways, including (1) reduced sample and reagent consumption, which leads to less waste generation and lower environmental impact; (2) efficient energy utilization because the miniaturized simultaneous analysis nature of microwell methods allows for faster and more efficient analysis; and (3) microwell assays amenable to automation, allowing for high precision and reproducibility of analytical results via minimizing of human error.…”

Three Innovative Green and High-Throughput Microwell Spectrophotometric Methods for the Quantitation of Ceritinib, a Potent Drug for the Treatment of ALK-Positive Non-Small Cell Lung Cancer: An Application to the Analysis of Capsules and Drug Uniformity Testing

“…This methodology has become highly valuable in pharmaceutical analysis for its alignment with green chemistry approaches [21][22][23], and for its capability for high-throughput analysis [24,25]. This methodology offers numerous advantages, including miniaturization, automation, parallelization, and significant advancements in both the environmental sustainability and efficient analysis of large sample sets [26][27][28]. Microwell analysis contributes to green chemistry in several ways: (1) it reduces sample and reagent consumption, leading to less waste generation and a lower environmental impact; (2) it optimizes energy utilization by enabling faster and more efficient analysis due to the simultaneous nature of miniaturized analysis; and (3) microwell assays are compatible with automation, ensuring high precision and reproducibility of analytical results by minimizing human errors.…”