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<p>The concurrent administration of narrow therapeutic window atypical antipsychotics: risperidone (RIS) and paliperidone (PAL), along with an antidepressant: sertraline (SERT), has become increasingly prevalent and clinically essential in contemporary psychiatric practice for managing complex psychiatric conditions. Moreover, this concurrent therapy strategy provides synergistic therapeutic benefits that could not be reached with monotherapy approaches. This work establishes development and validation of a robust and cost-effective thin-layer chromatography (TLC) method for the simultaneous determination of RIS/PAL and SERT in spiked human plasma with hydrocortisone (HYD) as an internal standard. A developing system combination of ethyl acetate–methanol–ethanol–formic acid–33% ammonia solution (2:4:4:0.2:0.1, <i>V/V</i>) was used for separation, and ultraviolet scanning at 237 nm for detection. To meet international standards for bioanalytical technique validation, validation parameters were examined following US Food and Drug Administration (FDA) recommendations, and the outcomes fell within the permitted ranges with % recovery ranging between 97.36 and 103.58, 100.87 and 102.05, and 94.96 and 104.96 for quality control samples of SERT, RIS, and PAL, respectively, with low %RSD indicating the proposed method’s accuracy and precision. Green analytical chemistry (GAC) principles were incorporated in this work through systematic environmental impact assessment of whiteness using red–green–blue (RGB) model, blueness using Blue Applicability Grade Index (BAGI) tool and greenness using Analytical GREEnness (AGREE) tool. The results were acceptable and satisfying. Additionally, a comprehensive assessment of drug–drug interactions (DDI) utilizing established online DDI assessment resource was performed to investigate possible DDI manifestation severity and ensure tolerability and efficacy of this combination.</p>

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Simultaneous thin-layer chromatography assay of concurrent psychotropic drugs risperidone, paliperidone, and sertraline in human plasma for treatment-resistant psychiatric disorders: in silico drug–drug interactions assessment

  • 期刊论文

  • 发表日期：

    2025年11月19日

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  • Raghda A. Emam,
  • Aml A. Emam,
  • Rehab M. Abdelfatah,
  • Basma H. Anwar

摘要

The concurrent administration of narrow therapeutic window atypical antipsychotics: risperidone (RIS) and paliperidone (PAL), along with an antidepressant: sertraline (SERT), has become increasingly prevalent and clinically essential in contemporary psychiatric practice for managing complex psychiatric conditions. Moreover, this concurrent therapy strategy provides synergistic therapeutic benefits that could not be reached with monotherapy approaches. This work establishes development and validation of a robust and cost-effective thin-layer chromatography (TLC) method for the simultaneous determination of RIS/PAL and SERT in spiked human plasma with hydrocortisone (HYD) as an internal standard. A developing system combination of ethyl acetate–methanol–ethanol–formic acid–33% ammonia solution (2:4:4:0.2:0.1, V/V) was used for separation, and ultraviolet scanning at 237 nm for detection. To meet international standards for bioanalytical technique validation, validation parameters were examined following US Food and Drug Administration (FDA) recommendations, and the outcomes fell within the permitted ranges with % recovery ranging between 97.36 and 103.58, 100.87 and 102.05, and 94.96 and 104.96 for quality control samples of SERT, RIS, and PAL, respectively, with low %RSD indicating the proposed method’s accuracy and precision. Green analytical chemistry (GAC) principles were incorporated in this work through systematic environmental impact assessment of whiteness using red–green–blue (RGB) model, blueness using Blue Applicability Grade Index (BAGI) tool and greenness using Analytical GREEnness (AGREE) tool. The results were acceptable and satisfying. Additionally, a comprehensive assessment of drug–drug interactions (DDI) utilizing established online DDI assessment resource was performed to investigate possible DDI manifestation severity and ensure tolerability and efficacy of this combination.