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Mathrusri Annapurna, Mukthinuthalapati
- Development and Validation of a New Stability Indicating Rp-uflc Method for the Estimation of Perampanel in Presence of Internal Standard
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Authors
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1 Department of Pharmaceutical Analysis, Gandhi Institute of Tecnology and Management ( Deemed to be University) GITAM Institute of Pharmacy, Vishakapatnam, Andhra Pradesh -530045, IN
1 Department of Pharmaceutical Analysis, Gandhi Institute of Tecnology and Management ( Deemed to be University) GITAM Institute of Pharmacy, Vishakapatnam, Andhra Pradesh -530045, IN
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Research Journal of Pharmacy and Technology, Vol 15, No 1 (2022), Pagination: 279-284Abstract
Perampanel is chemically α-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid receptor antagonist. Perampanel is used for the treatment of seizures which involve one part of brain both in adults as well as in children who are above four years. In the present study a new stability indicating reverse phase ultrafast liquid chromatographic method has been proposed for the quantification of Perampanel in presence of an internal standard, Rufinamide using water: acetonitrile as mobile phase. Linearity was observed over the concentration range 0.05-50 μg/mL with linear regression equation y = 1.3839x - 0.0302 (r2 = 0.9999). The LOD and LOQ were found to be 0.01451 μg/mL and 0.0437 μg/mL. Perampanel was exposed to different stress conditions such as acidic hydrolysis, alkaline hydrolysis, oxidation and thermal treatment and the proposed method was validated.Keywords
Stability indicating, Perampanel, Validation, UFLC, ICH guidelines.References
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- ICH Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization, 2003.
- ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization, 2005.
- A New Stability Indicating Rp-uflc Method for the Estimation Of Etoricoxib in Pharmaceutical Dosage Forms
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Authors
Affiliations
1 Department of Pharmaceutical Analysis, Gandhi Institute of Technology and Management (Deemed to be University), GITAM School of Pharmacy, Visakhapatnam, Andhra pradesh-530045,, IN
1 Department of Pharmaceutical Analysis, Gandhi Institute of Technology and Management (Deemed to be University), GITAM School of Pharmacy, Visakhapatnam, Andhra pradesh-530045,, IN
Source
Research Journal of Pharmacy and Technology, Vol 15, No 3 (2022), Pagination: 1219-1224Abstract
Etoricoxib is a selective COX-2 inhibitor and used as a non-steroidal anti-inflammatory drug. A new validated stability indicating RP-UFLC method has been developed for the estimation of Etoricoxib in pharmaceutical dosage forms (Tablets). Shimadzu UFLC system (PDA detector) with Agilent C18 column was chosen for the chromatographic study with mobile phase Acetonitrile: water (50: 50) and flow rate 0.8 mL/min (UV detection at 230 nm). Beer-Lambert’s law was obeyed over a concentration range 0.1-100 μg/mL. The linear regression equation was found to be y = 82642x -13032 (R2 = 0.9998). The LOD and LOQ was found to be and 0.0291 and 0.0894 μg/mL respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines. The proposed method is simple, precise, accurate and robust and can be applied for the quantification of Etoricoxib formulations.Keywords
Etoricoxib, RP-UFLC, Stability indicating, Validation, ICH guidelines.References
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- ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization (2005).
- ICH Stability testing of new drug substances and products Q1A (R2), International Conference on Harmonization (2003).