Simultaneous Estimation and Validation of Four Antiepileptic Drugs from Bulk and Formulations Using Reverse Phase HPLC

Abstract Epilepsy is a disorder of the central nervous system, in which the nerve cell activity in the brain is disturbed causing seizures. The objective was to develop an RP-HPLC method for consistent simultaneous quantitation of four antiepileptic drugs Levetiracetam (LVT), Lamotrigine (LTG), Phen...

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Main Authors: Pooja Kole, Sandhya Parameswaran
Format: Article
Language:English
Published: Universidade de São Paulo 2023-06-01
Series:Brazilian Journal of Pharmaceutical Sciences
Subjects:
Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502023000100386&tlng=en
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author Pooja Kole
Sandhya Parameswaran
author_facet Pooja Kole
Sandhya Parameswaran
author_sort Pooja Kole
collection DOAJ
description Abstract Epilepsy is a disorder of the central nervous system, in which the nerve cell activity in the brain is disturbed causing seizures. The objective was to develop an RP-HPLC method for consistent simultaneous quantitation of four antiepileptic drugs Levetiracetam (LVT), Lamotrigine (LTG), Phenobarbital (PBT) and Phenytoin (PTY). An isocratic method was developed on C18 column in JASCO HPLC using 5 mM potassium phosphate buffer (pH 6) and acetonitrile as the mobile phase at a flow rate of 1ml/min and detected at 230 nm using UV detector. The mean retention time for LVT, LTG, PBT and PTY were found as 2.55, 3.55, 4.65 and 5.99 minutes respectively. The method was validated as per ICH guidelines and was found to be acceptable. The %RSD value was <2.0 % thus stating the developed method was precise for the drugs in the given range. The accuracy values were within 85-115% of the recovery range. The specificity of the method was evaluated by an assay of marketed formulation, and it showed a percent content between 90-110% w/w for all the four drugs. The proposed analytical method was simple, accurate and robust and was precisely able to resolve the four major antiepileptic drugs. Hence, the current method can be applied successfully for routine examination of these drugs.
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spelling doaj.art-647d629b0d864eada115cd0f4a79ed852023-06-30T10:58:29ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences2175-97902023-06-015910.1590/s2175-97902023e20692Simultaneous Estimation and Validation of Four Antiepileptic Drugs from Bulk and Formulations Using Reverse Phase HPLCPooja KoleSandhya Parameswaranhttps://orcid.org/0000-0003-4136-791XAbstract Epilepsy is a disorder of the central nervous system, in which the nerve cell activity in the brain is disturbed causing seizures. The objective was to develop an RP-HPLC method for consistent simultaneous quantitation of four antiepileptic drugs Levetiracetam (LVT), Lamotrigine (LTG), Phenobarbital (PBT) and Phenytoin (PTY). An isocratic method was developed on C18 column in JASCO HPLC using 5 mM potassium phosphate buffer (pH 6) and acetonitrile as the mobile phase at a flow rate of 1ml/min and detected at 230 nm using UV detector. The mean retention time for LVT, LTG, PBT and PTY were found as 2.55, 3.55, 4.65 and 5.99 minutes respectively. The method was validated as per ICH guidelines and was found to be acceptable. The %RSD value was <2.0 % thus stating the developed method was precise for the drugs in the given range. The accuracy values were within 85-115% of the recovery range. The specificity of the method was evaluated by an assay of marketed formulation, and it showed a percent content between 90-110% w/w for all the four drugs. The proposed analytical method was simple, accurate and robust and was precisely able to resolve the four major antiepileptic drugs. Hence, the current method can be applied successfully for routine examination of these drugs.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502023000100386&tlng=enAntiepilepticHPLCSimultaneous estimationValidation
spellingShingle Pooja Kole
Sandhya Parameswaran
Simultaneous Estimation and Validation of Four Antiepileptic Drugs from Bulk and Formulations Using Reverse Phase HPLC
Brazilian Journal of Pharmaceutical Sciences
Antiepileptic
HPLC
Simultaneous estimation
Validation
title Simultaneous Estimation and Validation of Four Antiepileptic Drugs from Bulk and Formulations Using Reverse Phase HPLC
title_full Simultaneous Estimation and Validation of Four Antiepileptic Drugs from Bulk and Formulations Using Reverse Phase HPLC
title_fullStr Simultaneous Estimation and Validation of Four Antiepileptic Drugs from Bulk and Formulations Using Reverse Phase HPLC
title_full_unstemmed Simultaneous Estimation and Validation of Four Antiepileptic Drugs from Bulk and Formulations Using Reverse Phase HPLC
title_short Simultaneous Estimation and Validation of Four Antiepileptic Drugs from Bulk and Formulations Using Reverse Phase HPLC
title_sort simultaneous estimation and validation of four antiepileptic drugs from bulk and formulations using reverse phase hplc
topic Antiepileptic
HPLC
Simultaneous estimation
Validation
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502023000100386&tlng=en
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AT sandhyaparameswaran simultaneousestimationandvalidationoffourantiepilepticdrugsfrombulkandformulationsusingreversephasehplc