RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical Formulations

A simple, precise, accurate, economical and reproducible HPLC method for estimation of montelukast in tablet dosage form has been developed. Quantitative HPLC was performed with Shimadzu LC2010c HT with Winchrom Software with UV-Visible detector (SPD-IOA), PUMP (LC-IOAT) and (LC-IOATvp). Phenomenex...

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Main Authors: A. Patnaik, S. S. Panda, S. Sahoo, V. J. Patro
Format: Article
Language:English
Published: Wiley 2012-01-01
Series:E-Journal of Chemistry
Online Access:http://dx.doi.org/10.1155/2012/692424
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author A. Patnaik
S. S. Panda
S. Sahoo
V. J. Patro
author_facet A. Patnaik
S. S. Panda
S. Sahoo
V. J. Patro
author_sort A. Patnaik
collection DOAJ
description A simple, precise, accurate, economical and reproducible HPLC method for estimation of montelukast in tablet dosage form has been developed. Quantitative HPLC was performed with Shimadzu LC2010c HT with Winchrom Software with UV-Visible detector (SPD-IOA), PUMP (LC-IOAT) and (LC-IOATvp). Phenomenex C8, 5 μm, 25 cm × 4.6 mm i.d. column was used in the study. The mobile phase of ACN: Acetate buffer= 6.5:3.5 of pH 3 were used in this study. The conditions optimized were: flow rate (1 mL/minute), wavelength (222 nm) and run time was 20 min. Retention time was found to be 3.08 min. The linearity was found to be in the concentration range of 10-100 μg/mL. The developed method was evaluated in the assay of commercially available tablet moni containing 10 mg of montelukast. The amount of drug in tablet was found to be 10.34 mg/tab for the brand. Results of analysis were validated statistically and by recovery studies. The recovery studies 99.67% was indicative of the accuracy of proposed method. The precision was calculated as repeatability, inter and intraday variation (%RSD) for the drug. By using the method, stability of the drug has been studied.
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institution Kabale University
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publisher Wiley
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series E-Journal of Chemistry
spelling doaj-art-742d442b78784553aeedcb372c5f30832025-02-03T05:51:38ZengWileyE-Journal of Chemistry0973-49452090-98102012-01-0191354210.1155/2012/692424RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical FormulationsA. Patnaik0S. S. Panda1S. Sahoo2V. J. Patro3Saraswati College of Pharmaceutical Sciences, Yethbarpally(v), Moinabad (M), R. R. Dist, Andhra Pradesh, IndiaSaraswati College of Pharmaceutical Sciences, Yethbarpally(v), Moinabad (M), R. R. Dist, Andhra Pradesh, IndiaSaraswati College of Pharmaceutical Sciences, Yethbarpally(v), Moinabad (M), R. R. Dist, Andhra Pradesh, IndiaRoland Institute of Pharmaceutical Sciences, Khodasinghi, Berhampur, Ganjam, Orissa, IndiaA simple, precise, accurate, economical and reproducible HPLC method for estimation of montelukast in tablet dosage form has been developed. Quantitative HPLC was performed with Shimadzu LC2010c HT with Winchrom Software with UV-Visible detector (SPD-IOA), PUMP (LC-IOAT) and (LC-IOATvp). Phenomenex C8, 5 μm, 25 cm × 4.6 mm i.d. column was used in the study. The mobile phase of ACN: Acetate buffer= 6.5:3.5 of pH 3 were used in this study. The conditions optimized were: flow rate (1 mL/minute), wavelength (222 nm) and run time was 20 min. Retention time was found to be 3.08 min. The linearity was found to be in the concentration range of 10-100 μg/mL. The developed method was evaluated in the assay of commercially available tablet moni containing 10 mg of montelukast. The amount of drug in tablet was found to be 10.34 mg/tab for the brand. Results of analysis were validated statistically and by recovery studies. The recovery studies 99.67% was indicative of the accuracy of proposed method. The precision was calculated as repeatability, inter and intraday variation (%RSD) for the drug. By using the method, stability of the drug has been studied.http://dx.doi.org/10.1155/2012/692424
spellingShingle A. Patnaik
S. S. Panda
S. Sahoo
V. J. Patro
RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical Formulations
E-Journal of Chemistry
title RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical Formulations
title_full RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical Formulations
title_fullStr RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical Formulations
title_full_unstemmed RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical Formulations
title_short RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical Formulations
title_sort rp hplc method development and validation for the determination and stability indicative studies of montelukast in bulk and its pharmaceutical formulations
url http://dx.doi.org/10.1155/2012/692424
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