VALIDATION OF A SIMPLE REVERSED PHASE-HPLC METHOD FOR THE DETERMINATION OF BACLOFEN IN TABLETS
Baclofen is a muscle relaxant used as a first option to treat spasticity and muscle spasms in patients with spinal cord injuries, which is available in Brazil as 10 mg tablets. The compendia methods employ HPLC by ion pairing that requires the use of specific reagents and column conditioning, increa...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Universidade Federal do Rio Grande do Sul
2018-12-01
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| Series: | Drug Analytical Research |
| Online Access: | https://seer.ufrgs.br/index.php/dar/article/view/87929 |
| _version_ | 1797271703127064576 |
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| author | Juliana dos Santos Priscila Rosa Andréa Inês Horn Adams |
| author_facet | Juliana dos Santos Priscila Rosa Andréa Inês Horn Adams |
| author_sort | Juliana dos Santos |
| collection | DOAJ |
| description | Baclofen is a muscle relaxant used as a first option to treat spasticity and muscle spasms in patients with spinal cord injuries, which is available in Brazil as 10 mg tablets. The compendia methods employ HPLC by ion pairing that requires the use of specific reagents and column conditioning, increasing the waste generation and the cost of analysis. In this study, an isocratic, simple and stability-indicating HPLC method was validated to assay baclofen tablets. A C-18 column (Luna®, 150 x 4.6 mm, 5μm), mobile phase composed by triethylamine 10 mM pH 7.0, methanol and acetonitrile (80:15:5), flow rate 1 mL/min and detection at 220 nm was used. The baclofen retention time was 6.2 min and the method was linear in the range of 5 – 100 μg.mL-1 (r = 0.9999). Method selectivity was demonstrated by the forced degradation study and simultaneous analysis of baclofen impurity. The method showed accuracy (mean recovery 99.27%) and precision (RSD < 2%). The robustness was evaluated by factorial design, and the method was robust robust regarding the proposed variations. The developed method met the requirement of current guidelines, being indicative of stability and suitable for the determination of baclofen in tablets.
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| first_indexed | 2024-03-07T14:09:18Z |
| format | Article |
| id | doaj.art-ec732805150d4a4dbbdf994c75920380 |
| institution | Directory Open Access Journal |
| issn | 2527-2616 |
| language | English |
| last_indexed | 2024-03-07T14:09:18Z |
| publishDate | 2018-12-01 |
| publisher | Universidade Federal do Rio Grande do Sul |
| record_format | Article |
| series | Drug Analytical Research |
| spelling | doaj.art-ec732805150d4a4dbbdf994c759203802024-03-06T18:15:23ZengUniversidade Federal do Rio Grande do SulDrug Analytical Research2527-26162018-12-0122VALIDATION OF A SIMPLE REVERSED PHASE-HPLC METHOD FOR THE DETERMINATION OF BACLOFEN IN TABLETSJuliana dos Santos0Priscila Rosa1Andréa Inês Horn Adams2Post-Graduation Program in Pharmaceutical Sciences, Federal University of Santa MariaPost-Graduation Program in Pharmaceutical Sciences, Federal University of Santa MariaPost-Graduation Program in Pharmaceutical Sciences, Federal University of Santa MariaBaclofen is a muscle relaxant used as a first option to treat spasticity and muscle spasms in patients with spinal cord injuries, which is available in Brazil as 10 mg tablets. The compendia methods employ HPLC by ion pairing that requires the use of specific reagents and column conditioning, increasing the waste generation and the cost of analysis. In this study, an isocratic, simple and stability-indicating HPLC method was validated to assay baclofen tablets. A C-18 column (Luna®, 150 x 4.6 mm, 5μm), mobile phase composed by triethylamine 10 mM pH 7.0, methanol and acetonitrile (80:15:5), flow rate 1 mL/min and detection at 220 nm was used. The baclofen retention time was 6.2 min and the method was linear in the range of 5 – 100 μg.mL-1 (r = 0.9999). Method selectivity was demonstrated by the forced degradation study and simultaneous analysis of baclofen impurity. The method showed accuracy (mean recovery 99.27%) and precision (RSD < 2%). The robustness was evaluated by factorial design, and the method was robust robust regarding the proposed variations. The developed method met the requirement of current guidelines, being indicative of stability and suitable for the determination of baclofen in tablets. https://seer.ufrgs.br/index.php/dar/article/view/87929 |
| spellingShingle | Juliana dos Santos Priscila Rosa Andréa Inês Horn Adams VALIDATION OF A SIMPLE REVERSED PHASE-HPLC METHOD FOR THE DETERMINATION OF BACLOFEN IN TABLETS Drug Analytical Research |
| title | VALIDATION OF A SIMPLE REVERSED PHASE-HPLC METHOD FOR THE DETERMINATION OF BACLOFEN IN TABLETS |
| title_full | VALIDATION OF A SIMPLE REVERSED PHASE-HPLC METHOD FOR THE DETERMINATION OF BACLOFEN IN TABLETS |
| title_fullStr | VALIDATION OF A SIMPLE REVERSED PHASE-HPLC METHOD FOR THE DETERMINATION OF BACLOFEN IN TABLETS |
| title_full_unstemmed | VALIDATION OF A SIMPLE REVERSED PHASE-HPLC METHOD FOR THE DETERMINATION OF BACLOFEN IN TABLETS |
| title_short | VALIDATION OF A SIMPLE REVERSED PHASE-HPLC METHOD FOR THE DETERMINATION OF BACLOFEN IN TABLETS |
| title_sort | validation of a simple reversed phase hplc method for the determination of baclofen in tablets |
| url | https://seer.ufrgs.br/index.php/dar/article/view/87929 |
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