Development and validation of a LC- MS/MS Method for simultaneous quantitation of telmisartan and pioglitazone in rat plasma

In majority of complex diseases like diabetes, multiple medications are essential to achieve the better therapeutic control, as several mediators are involved in their pathogenesis. Likewise, although the primary component of diabetes care is to control blood glucose level, management of cardiovascu...

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Main Authors:	Das, Arindam, Sengupta, Pinaki, Ibrahim, Fuzianna, Chatterjee, Bappaditya, Mandal, Uttam Kumar
Format:	Conference or Workshop Item
Language:	English
Published:	2016
Subjects:	RS Pharmacy and materia medica
Online Access:	http://irep.iium.edu.my/52138/ http://irep.iium.edu.my/52138/7/52138.pdf

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spelling	iium-521382016-10-10T04:39:54Z http://irep.iium.edu.my/52138/ Development and validation of a LC- MS/MS Method for simultaneous quantitation of telmisartan and pioglitazone in rat plasma Das, Arindam Sengupta, Pinaki Ibrahim, Fuzianna Chatterjee, Bappaditya Mandal, Uttam Kumar RS Pharmacy and materia medica In majority of complex diseases like diabetes, multiple medications are essential to achieve the better therapeutic control, as several mediators are involved in their pathogenesis. Likewise, although the primary component of diabetes care is to control blood glucose level, management of cardiovascular risk factors should also be considered as vital one. Literature review reveals that the major and common health problems associated with pathophysiological mechanism for arterial damage in diabetes is hypertension. It is well established that angiotensin receptor blocker (ARB) class of antihypertensives are better tolerated antihypertensive. Amongst ARBs, telmisartan has fewer drug-related adverse events and provides superior blood pressure control. On the other hand, pioglitazone is a useful therapeutic drug for type 2 diabetes having beneficial pleiotropic effects on cardiovascular diseases. Thus, the combination therapy of telmisartan and pioglitazone can be beneficial to treat a patient suffering from diabetes and hypertension. A simple, high throughput and specific high-performance liquid chromatography tandem mass spectrometry (LC-MS/MS) method has been developed and validated according to the United States Food and Drug Administration (USFDA) guidelines for simultaneous quantification of telmisartan and pioglitazone in rat plasma. The bioanalytical method consists in the liquid-liquid extraction and quantitation by triple quadrupole mass spectrometer (API- 2000) using electrospray ionization technique, operating in multiple reaction monitoring (MRM) mode. The compounds were eluted isocratically injecting the aliquots of the processed samples on a C18 column with a mobile phase consisting of a mixture aqueous and organic phase. The ion transitions were monitored for the m/z ratio of telmisartan and pioglitazone. The response to telmisartan and pioglitazone was a linear function (r =0.99) of concentration over the entire linearity range. The validation results demonstrated that the method had satisfactory precision and accuracy across the calibration range. The Relative standard deviation (RSD) for intra- andinter-day precision was below 10%. The accuracy determined at three quality control levels was within 85 to 115%. This developed method proved reproducible and sensitive and can be used successfully to support a pharmacokinetic study. There was no evidence of instability of the analytes in rat plasma following stability studies. 2016 Conference or Workshop Item NonPeerReviewed application/pdf en http://irep.iium.edu.my/52138/7/52138.pdf Das, Arindam and Sengupta, Pinaki and Ibrahim, Fuzianna and Chatterjee, Bappaditya and Mandal, Uttam Kumar (2016) Development and validation of a LC- MS/MS Method for simultaneous quantitation of telmisartan and pioglitazone in rat plasma. In: 2nd International Conference on Industrial Pharmacy (ICIP 2016), 15th-16th Aug. 2016, Kuantan, Pahang. (Unpublished)
repository_type	Digital Repository
institution_category	Local University
institution	International Islamic University Malaysia
building	IIUM Repository
collection	Online Access
language	English
topic	RS Pharmacy and materia medica
spellingShingle	RS Pharmacy and materia medica Das, Arindam Sengupta, Pinaki Ibrahim, Fuzianna Chatterjee, Bappaditya Mandal, Uttam Kumar Development and validation of a LC- MS/MS Method for simultaneous quantitation of telmisartan and pioglitazone in rat plasma
description	In majority of complex diseases like diabetes, multiple medications are essential to achieve the better therapeutic control, as several mediators are involved in their pathogenesis. Likewise, although the primary component of diabetes care is to control blood glucose level, management of cardiovascular risk factors should also be considered as vital one. Literature review reveals that the major and common health problems associated with pathophysiological mechanism for arterial damage in diabetes is hypertension. It is well established that angiotensin receptor blocker (ARB) class of antihypertensives are better tolerated antihypertensive. Amongst ARBs, telmisartan has fewer drug-related adverse events and provides superior blood pressure control. On the other hand, pioglitazone is a useful therapeutic drug for type 2 diabetes having beneficial pleiotropic effects on cardiovascular diseases. Thus, the combination therapy of telmisartan and pioglitazone can be beneficial to treat a patient suffering from diabetes and hypertension. A simple, high throughput and specific high-performance liquid chromatography tandem mass spectrometry (LC-MS/MS) method has been developed and validated according to the United States Food and Drug Administration (USFDA) guidelines for simultaneous quantification of telmisartan and pioglitazone in rat plasma. The bioanalytical method consists in the liquid-liquid extraction and quantitation by triple quadrupole mass spectrometer (API- 2000) using electrospray ionization technique, operating in multiple reaction monitoring (MRM) mode. The compounds were eluted isocratically injecting the aliquots of the processed samples on a C18 column with a mobile phase consisting of a mixture aqueous and organic phase. The ion transitions were monitored for the m/z ratio of telmisartan and pioglitazone. The response to telmisartan and pioglitazone was a linear function (r =0.99) of concentration over the entire linearity range. The validation results demonstrated that the method had satisfactory precision and accuracy across the calibration range. The Relative standard deviation (RSD) for intra- andinter-day precision was below 10%. The accuracy determined at three quality control levels was within 85 to 115%. This developed method proved reproducible and sensitive and can be used successfully to support a pharmacokinetic study. There was no evidence of instability of the analytes in rat plasma following stability studies.
format	Conference or Workshop Item
author	Das, Arindam Sengupta, Pinaki Ibrahim, Fuzianna Chatterjee, Bappaditya Mandal, Uttam Kumar
author_facet	Das, Arindam Sengupta, Pinaki Ibrahim, Fuzianna Chatterjee, Bappaditya Mandal, Uttam Kumar
author_sort	Das, Arindam
title	Development and validation of a LC- MS/MS Method for simultaneous quantitation of telmisartan and pioglitazone in rat plasma
title_short	Development and validation of a LC- MS/MS Method for simultaneous quantitation of telmisartan and pioglitazone in rat plasma
title_full	Development and validation of a LC- MS/MS Method for simultaneous quantitation of telmisartan and pioglitazone in rat plasma
title_fullStr	Development and validation of a LC- MS/MS Method for simultaneous quantitation of telmisartan and pioglitazone in rat plasma
title_full_unstemmed	Development and validation of a LC- MS/MS Method for simultaneous quantitation of telmisartan and pioglitazone in rat plasma
title_sort	development and validation of a lc- ms/ms method for simultaneous quantitation of telmisartan and pioglitazone in rat plasma
publishDate	2016
url	http://irep.iium.edu.my/52138/ http://irep.iium.edu.my/52138/7/52138.pdf
first_indexed	2023-09-18T21:13:55Z
last_indexed	2023-09-18T21:13:55Z
_version_	1777411435368808448

Development and validation of a LC- MS/MS Method for simultaneous quantitation of telmisartan and pioglitazone in rat plasma

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