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Stability Indicating HPLC-DAD Method for the Determination of Oxcarbazepine-An Anticonvulsant


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1 Department of Pharmaceutical Ananlysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM(Deemed to be University), Vishakapatnam, Andhra Pradesh-530045, India
     

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Oxcarbazepine is an anticonvulsant drug used for the treatment of epilepsy. It acts by decreasing the abnormal electrical activity in the brain. A new stability indicating HPLC method was developed for the quantification of Oxcarbazepine in tablets. Waters e2695 Separations module with Waters 2489 UV detector with Hypersil BDS C18 column (250 mm x 4.6 mm, 5μ) was operated with column temperature 50°C. The detector was monitored at 215 nm and the chromatographic study was run for 20 min. Linearity was observed over 5.0-150 μg/mL with linear regression equation y = 47,910x + 6493.8 with correlation coefficient R² = 0.9999. The LOQ and LOD were found to be 4.5129 μg/mL and 1.4898 μg/mL respectively. Forced degradation studies were performed for Oxcarbazepine capsules and the method was validated as per ICH guidelines.

Keywords

Oxcarbazepine, RP-HPLC, Stability Indicating, Validation, ICH Guidelines.
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  • Stability Indicating HPLC-DAD Method for the Determination of Oxcarbazepine-An Anticonvulsant

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Authors

Debi Prasad Pradhan
Department of Pharmaceutical Ananlysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM(Deemed to be University), Vishakapatnam, Andhra Pradesh-530045, India
Mukthinuthalapati Mathrusri Annapurna
Department of Pharmaceutical Ananlysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM(Deemed to be University), Vishakapatnam, Andhra Pradesh-530045, India

Abstract


Oxcarbazepine is an anticonvulsant drug used for the treatment of epilepsy. It acts by decreasing the abnormal electrical activity in the brain. A new stability indicating HPLC method was developed for the quantification of Oxcarbazepine in tablets. Waters e2695 Separations module with Waters 2489 UV detector with Hypersil BDS C18 column (250 mm x 4.6 mm, 5μ) was operated with column temperature 50°C. The detector was monitored at 215 nm and the chromatographic study was run for 20 min. Linearity was observed over 5.0-150 μg/mL with linear regression equation y = 47,910x + 6493.8 with correlation coefficient R² = 0.9999. The LOQ and LOD were found to be 4.5129 μg/mL and 1.4898 μg/mL respectively. Forced degradation studies were performed for Oxcarbazepine capsules and the method was validated as per ICH guidelines.

Keywords


Oxcarbazepine, RP-HPLC, Stability Indicating, Validation, ICH Guidelines.

References