Design of experiments and white analytical chemistry-driven green and sensitive spectrofluorimetric estimation of pregabalin in its pharmaceutical dosage forms and spiked human plasma
Abstract Background Pregabalin (PGB) is a medication with anticonvulsant, analgesic and anxiolytic properties, employed in the treatment of epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, opioid withdrawal syndrome and generalized anxiety disorder. Several spectrofluorimetric techni...
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| Format: | Article |
| Language: | English |
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SpringerOpen
2024-03-01
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| Series: | Future Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s43094-024-00615-3 |
| _version_ | 1797247381595488256 |
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| author | Pintu Prajapati Veera Shakar Pulusu Shailesh Shah |
| author_facet | Pintu Prajapati Veera Shakar Pulusu Shailesh Shah |
| author_sort | Pintu Prajapati |
| collection | DOAJ |
| description | Abstract Background Pregabalin (PGB) is a medication with anticonvulsant, analgesic and anxiolytic properties, employed in the treatment of epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, opioid withdrawal syndrome and generalized anxiety disorder. Several spectrofluorimetric techniques have been documented for the determination of PGB in pharmaceutical dosage forms. However, these published methods typically involve the use of expensive and toxic organic solvents and reagents, as well as high reaction temperatures for PGB analysis. These components pose risks to aquatic life and the environment, making them less environmentally friendly and user-friendly. A recent advancement in analytical chemistry has introduced a white analytical approach, providing an economical, eco-friendly and user-friendly method for the development of analytical procedures. Objectives Therefore, a green and sensitive spectrofluorimetric determination of PGB, guided by white analytical chemistry principles, has been conducted utilizing distilled water as an environmentally friendly solvent. Methods The establishment of the spectrofluorimetric method involved employing the design of experiments approach to ensure a robust, precise and accurate estimation of PGB. Response surface analysis and optimization of critical procedural variables and responses were carried out using the central composite design. The validation of the developed method adhered to the guidelines outlined in ICH (International Council for Harmonization) Q2 (R1) and M10. Results The established spectrofluorimetric method was utilized to determine the PGB content in commercially available formulations and human plasma samples spiked with PGB. The obtained results were in accordance with the labeled claim of PGB in the formulations. The recovery of PGB in the spiked human plasma samples ranged from 85 to 90% of the spiked amount. Conclusions The greenness profiles of the published and suggested spectrofluorimetric methods for PGB estimation were evaluated and compared using the AGREE calculator, GAPI software and ESA tool. The suggested method demonstrated sensitivity, robustness, environmental friendliness and user-friendliness. |
| first_indexed | 2024-04-24T19:57:48Z |
| format | Article |
| id | doaj.art-1815f4b1ecae42708f0b6810c4e4fd53 |
| institution | Directory Open Access Journal |
| issn | 2314-7253 |
| language | English |
| last_indexed | 2024-04-24T19:57:48Z |
| publishDate | 2024-03-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Future Journal of Pharmaceutical Sciences |
| spelling | doaj.art-1815f4b1ecae42708f0b6810c4e4fd532024-03-24T12:12:45ZengSpringerOpenFuture Journal of Pharmaceutical Sciences2314-72532024-03-0110111510.1186/s43094-024-00615-3Design of experiments and white analytical chemistry-driven green and sensitive spectrofluorimetric estimation of pregabalin in its pharmaceutical dosage forms and spiked human plasmaPintu Prajapati0Veera Shakar Pulusu1Shailesh Shah2Department of Quality Assurance, Maliba Pharmacy CollegeDepartment of Chemistry and Biochemistry, Ohio UniversityDepartment of Quality Assurance, Maliba Pharmacy CollegeAbstract Background Pregabalin (PGB) is a medication with anticonvulsant, analgesic and anxiolytic properties, employed in the treatment of epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, opioid withdrawal syndrome and generalized anxiety disorder. Several spectrofluorimetric techniques have been documented for the determination of PGB in pharmaceutical dosage forms. However, these published methods typically involve the use of expensive and toxic organic solvents and reagents, as well as high reaction temperatures for PGB analysis. These components pose risks to aquatic life and the environment, making them less environmentally friendly and user-friendly. A recent advancement in analytical chemistry has introduced a white analytical approach, providing an economical, eco-friendly and user-friendly method for the development of analytical procedures. Objectives Therefore, a green and sensitive spectrofluorimetric determination of PGB, guided by white analytical chemistry principles, has been conducted utilizing distilled water as an environmentally friendly solvent. Methods The establishment of the spectrofluorimetric method involved employing the design of experiments approach to ensure a robust, precise and accurate estimation of PGB. Response surface analysis and optimization of critical procedural variables and responses were carried out using the central composite design. The validation of the developed method adhered to the guidelines outlined in ICH (International Council for Harmonization) Q2 (R1) and M10. Results The established spectrofluorimetric method was utilized to determine the PGB content in commercially available formulations and human plasma samples spiked with PGB. The obtained results were in accordance with the labeled claim of PGB in the formulations. The recovery of PGB in the spiked human plasma samples ranged from 85 to 90% of the spiked amount. Conclusions The greenness profiles of the published and suggested spectrofluorimetric methods for PGB estimation were evaluated and compared using the AGREE calculator, GAPI software and ESA tool. The suggested method demonstrated sensitivity, robustness, environmental friendliness and user-friendliness.https://doi.org/10.1186/s43094-024-00615-3Green and sensitive spectrofluorimetric methodPregabalinWhite analytical chemistryDesign of experimentsCentral composite design |
| spellingShingle | Pintu Prajapati Veera Shakar Pulusu Shailesh Shah Design of experiments and white analytical chemistry-driven green and sensitive spectrofluorimetric estimation of pregabalin in its pharmaceutical dosage forms and spiked human plasma Future Journal of Pharmaceutical Sciences Green and sensitive spectrofluorimetric method Pregabalin White analytical chemistry Design of experiments Central composite design |
| title | Design of experiments and white analytical chemistry-driven green and sensitive spectrofluorimetric estimation of pregabalin in its pharmaceutical dosage forms and spiked human plasma |
| title_full | Design of experiments and white analytical chemistry-driven green and sensitive spectrofluorimetric estimation of pregabalin in its pharmaceutical dosage forms and spiked human plasma |
| title_fullStr | Design of experiments and white analytical chemistry-driven green and sensitive spectrofluorimetric estimation of pregabalin in its pharmaceutical dosage forms and spiked human plasma |
| title_full_unstemmed | Design of experiments and white analytical chemistry-driven green and sensitive spectrofluorimetric estimation of pregabalin in its pharmaceutical dosage forms and spiked human plasma |
| title_short | Design of experiments and white analytical chemistry-driven green and sensitive spectrofluorimetric estimation of pregabalin in its pharmaceutical dosage forms and spiked human plasma |
| title_sort | design of experiments and white analytical chemistry driven green and sensitive spectrofluorimetric estimation of pregabalin in its pharmaceutical dosage forms and spiked human plasma |
| topic | Green and sensitive spectrofluorimetric method Pregabalin White analytical chemistry Design of experiments Central composite design |
| url | https://doi.org/10.1186/s43094-024-00615-3 |
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