Simultaneous Determination of Ezetimibe and Simvastatin in Pharmaceutical Formulations by Dual-Mode Gradient LC

Özaltı́n, Nuran; Uçaktürk, Ebru

doi:10.1365/s10337-007-0303-x

Cited by 27 publications

(16 citation statements)

References 27 publications

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“…There are a number of methods describing simultaneous determination of simvastatin and ezetimibe from their combination drug products [22][23][24][25]. Stability indicating studies on combined pharmaceutical products of simvastatin and ezetimibe have also been published [24,25].…”

Section: Simvastatinmentioning

confidence: 99%

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

Nigović¹,

Mornar²,

Sertić³

2012

Chromatography - The Most Versatile Method of Chemical Analysis

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Section: Simvastatinmentioning

confidence: 99%

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

Nigović¹,

Mornar²,

Sertić³

2012

Chromatography - The Most Versatile Method of Chemical Analysis

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“…It does not appear to compromise the absorption of fat-soluble vitamins, triglycerides and bile acids [17][18][19]. Many analytical methods are reported in the literature for ezetimibe using different techniques [20][21][22][23][24][25][26][27][28][29].…”

Section: Rosuvastatin Figure (1) Is the Calcium Salt Of (E)-7-[4-(4-fmentioning

confidence: 99%

Lc Determination of Rosuvastatin and Ezetimibe in Human Plasma

Ashfaq

Ahmad

Khan

et al. 2013

J. Chil. Chem. Soc.

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A simple, precise, sensitive and validated reverse-phase high performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous estimation of rosuvastatin and ezetimibe in human plasma. The method involved protein precipitation and extraction of both drugs from plasma using acetonitrile and then separation on a C-18 column. Both the analytes were detected at a wavelength of 240 nm using diode array detector. Mobile phase for the said separation consists of a mixture of 1.5% phosphoric acid and acetonitrile in 30:70, v/v ratio. Linearity was in the range of 0.32-267 mg/mL for rosuvastatin and 0.08-67 mg/mL for ezetimibe with coefficient of determination between 0.9997 and 0.9967. Limit of detection was 0.106 mg/mL for rosuvastatin and 0.026 mg/mL for ezetimibe whereas limit of quantification was 0.32 mg/mL and 0.08 mg/mL for rosuvastatin and ezetimibe respectively. Recovery of both the analytes was greater than 75% with RSD less than 15 %. The total run time was less than five min for the two components. The developed method can be fruitfully employed for the determination of these two drugs in human plasma. 1-INTRODUCTION-enoic acid and a competitive inhibitor of HMG-CoA reductase [1][2]. It is used in the treatment of hypercholesterolemia and dyslipidemia [3][4]. Rosuvastatin is very effective in reducing low density lipoprotein cholesterol [5] and many studies have demonstrated its efficacy greater than other drugs of its class such as atorvastatin, simvastatin and pravastatin [5][6][7]. During literature review many methods were found reporting separation of rosuvastatin like capillary zone electrophoresis [8], Spectrophotometry [9-10] and HPLC [11][12][13][14].formulations.We are currently engaged in the development of simple HPLC methods for the determination of binary combinations of different classes of drugs including antihyperlipidemic drugs [21,22,[36][37][38][39][40][41][42][43][44][45][46]. The present work was therefore planned to develop a simple HPLC method to determine rosuvastatin and ezetimibe simultaneously in human plasma. During this study, a simple, economic and sensitive HPLC method with run time less than five min was developed in human plasma. The developed method have superiority over the Varghese et al method in that its linear range is 0.32-267 mg/mL for rosuvastatin and 0.08-67 mg/mL for ezetimibe and also the method is applied for human plasma. The method could have the potential to be used for any sort of studies planned for conducting in human plasma. Literature survey also revealed some analytical methods for the simultaneous determination of rosuvastatin and ezetimibe. These include spectrophotometry [30][31], HPTLC [32], Micellar liquid chromatography [33] and simultaneous equation method [34]. Recently Varghese et al [35] reported an RP-HPLC method for the simultaneous determination of rosuvastatin and ezetimibe. The method has some limitations as its linear range were narrow and have high detection limits of 0.5µg/mL for both drugs. Secondly the ...

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“…These procedures include spectrophotometric comprising simultaneous determination of EZE and atorvastatin calcium in pharmaceutical dosage form [3], also, simvastatin and fluvastatin in human plasma and pharmaceutical formulation [4], TLC [5][6][7], LC [3,[8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26], Capillary Zone Electrophoresis (CZE) [27,28] and GC [29] methods.…”

Section: Introductionmentioning

confidence: 99%

Derivative spectrophotometric method for simultaneous determination of ezetimibe and simvastatin in combined tablets

2010

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KEYWORDSThe introduced study portrays the development and validation of an effortless, speedy and selective first order derivative zero-crossing spectrophotometric method to estimate ezetimibe and simvastatin simultaneously in combined drug products over and above in the presence of ezetimibe alkaline degradation products. Ezetimibe and its alkaline degradates spectra showed zero-crossing point at 249 nm, so the amplitude at 249 nm could be used for calculating the concentration of simvastatin. While simvastatin and ezetimibe alkaline degradates spectra showed a zero-reading value at 261 nm, so ezetimibe could be determined by measuring the amplitude at 261 nm. Regression plots revealed good linear relationships in the concentration range 1-16 µg/mL with accuracy checked by conducting recovery studies; average recovery was 99.61 ± 1.183 and 100.47 ± 1.310 for ezetimibe and simvastatin, respectively. The suggested first derivative spectrophotometric method was successfully applied for the determination of the cited drugs in "Inegy 10/10, 10/20 and 10/40 tablets". Satisfactory results were obtained for the recovery of both drugs and were in good agreement with the labeled amounts. Method validation was estimated according to USP guidelines.

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Simultaneous Determination of Ezetimibe and Simvastatin in Pharmaceutical Formulations by Dual-Mode Gradient LC

Cited by 27 publications

References 27 publications

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

Lc Determination of Rosuvastatin and Ezetimibe in Human Plasma

Derivative spectrophotometric method for simultaneous determination of ezetimibe and simvastatin in combined tablets

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