Chemometric technique for the optimization of chromatographic system: Simultaneous HPLC determination of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin used in combined cardiovascular therapy

Developed and optimized a validated isocratic reverse phase HPLC separation of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin in pharmaceutical preparation using response surface methodology. The separation was carried out by using phenomenex C18 column (15 cm × 4.6 mm id, 5 μm particle size)...

Full description

Bibliographic Details
Main Authors: V. Sree Janardhanan, R. Manavalan, K. Valliappan
Format: Article
Language:English
Published: Elsevier 2016-11-01
Series:Arabian Journal of Chemistry
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1878535212000470
_version_ 1828390984193409024
author V. Sree Janardhanan
R. Manavalan
K. Valliappan
author_facet V. Sree Janardhanan
R. Manavalan
K. Valliappan
author_sort V. Sree Janardhanan
collection DOAJ
description Developed and optimized a validated isocratic reverse phase HPLC separation of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin in pharmaceutical preparation using response surface methodology. The separation was carried out by using phenomenex C18 column (15 cm × 4.6 mm id, 5 μm particle size) and UV detection at 239 nm. The ranges of the independent variables used for the optimization were MeCN: 33–38%, buffer conc.: 10–20 mM and flow rate: 1–2 ml/min. The influence of these independent variables on the output responses: capacity factor of the first peak (k1), resolutions of the 2nd and 3rd peak (Rs2,3), and capacity factor of the fifth peak (k5) were evaluated. Using this strategy, a mathematical model was defined and a response surface was derived for the separation. The three responses were simultaneously optimized by using Derringer's desirability functions. Optimum conditions chosen for the assay were MeCN, MeOH, 20 mM K2HPO4 (pH 3.0 ± 0.2) solution (34.27:20:45.73 v/v/v) and flow rate 2 ml/min. Total chromatographic analysis time per sample was approximately 10 min. The optimized assay condition was validated as per the ICH guidelines and applied for the quantitative analysis of Rosavel EZ, Avas-EZ and Lipisar 20 tablet. The developed method was simple, accurate and precise. Hence, it can be employed for the routine analysis in quality control laboratories.
first_indexed 2024-12-10T06:55:23Z
format Article
id doaj.art-79b2ffe8ef124b47a3f59d86c3540e3c
institution Directory Open Access Journal
issn 1878-5352
language English
last_indexed 2024-12-10T06:55:23Z
publishDate 2016-11-01
publisher Elsevier
record_format Article
series Arabian Journal of Chemistry
spelling doaj.art-79b2ffe8ef124b47a3f59d86c3540e3c2022-12-22T01:58:27ZengElsevierArabian Journal of Chemistry1878-53522016-11-019S2S1378S138710.1016/j.arabjc.2012.03.001Chemometric technique for the optimization of chromatographic system: Simultaneous HPLC determination of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin used in combined cardiovascular therapyV. Sree JanardhananR. ManavalanK. ValliappanDeveloped and optimized a validated isocratic reverse phase HPLC separation of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin in pharmaceutical preparation using response surface methodology. The separation was carried out by using phenomenex C18 column (15 cm × 4.6 mm id, 5 μm particle size) and UV detection at 239 nm. The ranges of the independent variables used for the optimization were MeCN: 33–38%, buffer conc.: 10–20 mM and flow rate: 1–2 ml/min. The influence of these independent variables on the output responses: capacity factor of the first peak (k1), resolutions of the 2nd and 3rd peak (Rs2,3), and capacity factor of the fifth peak (k5) were evaluated. Using this strategy, a mathematical model was defined and a response surface was derived for the separation. The three responses were simultaneously optimized by using Derringer's desirability functions. Optimum conditions chosen for the assay were MeCN, MeOH, 20 mM K2HPO4 (pH 3.0 ± 0.2) solution (34.27:20:45.73 v/v/v) and flow rate 2 ml/min. Total chromatographic analysis time per sample was approximately 10 min. The optimized assay condition was validated as per the ICH guidelines and applied for the quantitative analysis of Rosavel EZ, Avas-EZ and Lipisar 20 tablet. The developed method was simple, accurate and precise. Hence, it can be employed for the routine analysis in quality control laboratories.http://www.sciencedirect.com/science/article/pii/S1878535212000470AtorvastatinCentral composite designDerringer's desirability functionEzetimibeRosuvastatinTelmisartan
spellingShingle V. Sree Janardhanan
R. Manavalan
K. Valliappan
Chemometric technique for the optimization of chromatographic system: Simultaneous HPLC determination of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin used in combined cardiovascular therapy
Arabian Journal of Chemistry
Atorvastatin
Central composite design
Derringer's desirability function
Ezetimibe
Rosuvastatin
Telmisartan
title Chemometric technique for the optimization of chromatographic system: Simultaneous HPLC determination of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin used in combined cardiovascular therapy
title_full Chemometric technique for the optimization of chromatographic system: Simultaneous HPLC determination of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin used in combined cardiovascular therapy
title_fullStr Chemometric technique for the optimization of chromatographic system: Simultaneous HPLC determination of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin used in combined cardiovascular therapy
title_full_unstemmed Chemometric technique for the optimization of chromatographic system: Simultaneous HPLC determination of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin used in combined cardiovascular therapy
title_short Chemometric technique for the optimization of chromatographic system: Simultaneous HPLC determination of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin used in combined cardiovascular therapy
title_sort chemometric technique for the optimization of chromatographic system simultaneous hplc determination of rosuvastatin telmisartan ezetimibe and atorvastatin used in combined cardiovascular therapy
topic Atorvastatin
Central composite design
Derringer's desirability function
Ezetimibe
Rosuvastatin
Telmisartan
url http://www.sciencedirect.com/science/article/pii/S1878535212000470
work_keys_str_mv AT vsreejanardhanan chemometrictechniquefortheoptimizationofchromatographicsystemsimultaneoushplcdeterminationofrosuvastatintelmisartanezetimibeandatorvastatinusedincombinedcardiovasculartherapy
AT rmanavalan chemometrictechniquefortheoptimizationofchromatographicsystemsimultaneoushplcdeterminationofrosuvastatintelmisartanezetimibeandatorvastatinusedincombinedcardiovasculartherapy
AT kvalliappan chemometrictechniquefortheoptimizationofchromatographicsystemsimultaneoushplcdeterminationofrosuvastatintelmisartanezetimibeandatorvastatinusedincombinedcardiovasculartherapy