tability-indicating RP-HPLC method for simultaneous quantitation of tramadol and aceclofenac in presence of their major degradation products: Method development and validation

Primary objective of this study was to develop a stability indicating reverse phase high performance liquid chromatography method for simultaneous quantitation of tramadol and aceclofenac in presence of their degradation products. The drugs were subjected to various International Conference on Harmo...

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Main Authors:	., Md. Gousuddin, Sengupta, Pinaki, Chatterjee, Bappaditya, Das, Sreemoy Kanti
Format:	Article
Language:	English English
Published:	Taylor & Francis 2017
Subjects:	RS Pharmacy and materia medica
Online Access:	http://irep.iium.edu.my/58654/ http://irep.iium.edu.my/58654/ http://irep.iium.edu.my/58654/ http://irep.iium.edu.my/58654/1/58654_Stability-indicating%20RP-HPLC_MYRA.pdf http://irep.iium.edu.my/58654/2/58654_Stability-indicating%20RP-HPLC_SCOPUS.pdf

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spelling	iium-586542018-03-21T08:47:06Z http://irep.iium.edu.my/58654/ tability-indicating RP-HPLC method for simultaneous quantitation of tramadol and aceclofenac in presence of their major degradation products: Method development and validation ., Md. Gousuddin Sengupta, Pinaki Chatterjee, Bappaditya Das, Sreemoy Kanti RS Pharmacy and materia medica Primary objective of this study was to develop a stability indicating reverse phase high performance liquid chromatography method for simultaneous quantitation of tramadol and aceclofenac in presence of their degradation products. The drugs were subjected to various International Conference on Harmonization recommended stress conditions, such as acid hydrolysis, alkaline hydrolysis, peroxide oxidation, thermolysis and photolysis. The major degradation products got well resoluted from the analytes in HPLC analysis with a mobile phase composed of a mixture of 0.01 M ammonium acetate buffer (pH 6.5) and acetonitrile (65:35, v/v) through a Phenomenex Gemini C18 (250 mm x 4.6 mm, 5 µm particle size) column. The method was linear over a range of 15-60 µg/ ml for tramadol and 40-160 µg/ ml for aceclofenac concentration. The analytes were detected at a wavelength of 270 nm. The method was validated and found to be specific, accurate, precise, stable and robust for its intended use. The method can be recommended for its future use in routine quality control, accelerated and real time stability analysis of the formulations containing tramadol and aceclofenac combination. Taylor & Francis 2017-10-21 Article PeerReviewed application/pdf en http://irep.iium.edu.my/58654/1/58654_Stability-indicating%20RP-HPLC_MYRA.pdf application/pdf en http://irep.iium.edu.my/58654/2/58654_Stability-indicating%20RP-HPLC_SCOPUS.pdf ., Md. Gousuddin and Sengupta, Pinaki and Chatterjee, Bappaditya and Das, Sreemoy Kanti (2017) tability-indicating RP-HPLC method for simultaneous quantitation of tramadol and aceclofenac in presence of their major degradation products: Method development and validation. Journal of Liquid Chromatography & Related Technologies, 40 (17). pp. 887-893. (In Press) https://www.tandfonline.com/doi/abs/10.1080/10826076.2017.1381849?journalCode=ljlc20 10.1080/10826076.2017.1381849
repository_type	Digital Repository
institution_category	Local University
institution	International Islamic University Malaysia
building	IIUM Repository
collection	Online Access
language	English English
topic	RS Pharmacy and materia medica
spellingShingle	RS Pharmacy and materia medica ., Md. Gousuddin Sengupta, Pinaki Chatterjee, Bappaditya Das, Sreemoy Kanti tability-indicating RP-HPLC method for simultaneous quantitation of tramadol and aceclofenac in presence of their major degradation products: Method development and validation
description	Primary objective of this study was to develop a stability indicating reverse phase high performance liquid chromatography method for simultaneous quantitation of tramadol and aceclofenac in presence of their degradation products. The drugs were subjected to various International Conference on Harmonization recommended stress conditions, such as acid hydrolysis, alkaline hydrolysis, peroxide oxidation, thermolysis and photolysis. The major degradation products got well resoluted from the analytes in HPLC analysis with a mobile phase composed of a mixture of 0.01 M ammonium acetate buffer (pH 6.5) and acetonitrile (65:35, v/v) through a Phenomenex Gemini C18 (250 mm x 4.6 mm, 5 µm particle size) column. The method was linear over a range of 15-60 µg/ ml for tramadol and 40-160 µg/ ml for aceclofenac concentration. The analytes were detected at a wavelength of 270 nm. The method was validated and found to be specific, accurate, precise, stable and robust for its intended use. The method can be recommended for its future use in routine quality control, accelerated and real time stability analysis of the formulations containing tramadol and aceclofenac combination.
format	Article
author	., Md. Gousuddin Sengupta, Pinaki Chatterjee, Bappaditya Das, Sreemoy Kanti
author_facet	., Md. Gousuddin Sengupta, Pinaki Chatterjee, Bappaditya Das, Sreemoy Kanti
author_sort	., Md. Gousuddin
title	tability-indicating RP-HPLC method for simultaneous quantitation of tramadol and aceclofenac in presence of their major degradation products: Method development and validation
title_short	tability-indicating RP-HPLC method for simultaneous quantitation of tramadol and aceclofenac in presence of their major degradation products: Method development and validation
title_full	tability-indicating RP-HPLC method for simultaneous quantitation of tramadol and aceclofenac in presence of their major degradation products: Method development and validation
title_fullStr	tability-indicating RP-HPLC method for simultaneous quantitation of tramadol and aceclofenac in presence of their major degradation products: Method development and validation
title_full_unstemmed	tability-indicating RP-HPLC method for simultaneous quantitation of tramadol and aceclofenac in presence of their major degradation products: Method development and validation
title_sort	tability-indicating rp-hplc method for simultaneous quantitation of tramadol and aceclofenac in presence of their major degradation products: method development and validation
publisher	Taylor & Francis
publishDate	2017
url	http://irep.iium.edu.my/58654/ http://irep.iium.edu.my/58654/ http://irep.iium.edu.my/58654/ http://irep.iium.edu.my/58654/1/58654_Stability-indicating%20RP-HPLC_MYRA.pdf http://irep.iium.edu.my/58654/2/58654_Stability-indicating%20RP-HPLC_SCOPUS.pdf
first_indexed	2018-09-07T07:47:54Z
last_indexed	2018-09-07T07:47:54Z
_version_	1610934097525342208

tability-indicating RP-HPLC method for simultaneous quantitation of tramadol and aceclofenac in presence of their major degradation products: Method development and validation

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