Stability-Indicating HPTLC Method for Simultaneous Determination of Ezetimibe and Simvastatin

Dixit, Rahul; Barhate, Chandrashekhar R.; Nagarsenker, Mangal S.

doi:10.1365/s10337-007-0459-4

Cited by 39 publications

(26 citation statements)

References 15 publications

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“…The first step is to test all the published TLC-Densitometric developing systems [19,24] [in the first method the mobile phase was composed of chloroform: benzene: methanol: acetic acid (6:3:1:0.1 by volume) and the detection of the developed spots was carried out at 250 nm while in the second method the mobile phase was composed of n-hexane: acetone (6:4 v/v) and the detection of the developed spots was carried out at 234 nm]. Unfortunately, none of them was able to separate all the EZ/AT and EZ/SIM mixtures together using one developing system.…”

Section: Methods Optimizationmentioning

confidence: 99%

“…It is frequently prescribed for the treatment of hypercholesterolemia and was shown to significantly decrease the mortality associated with coronary heart diseases [17]. Combinations of either EZ/AT or EZ/ SIM have the advantages of greater therapeutic effects than either drug alone [21][22][23][24]. These combinations have significant effects on reducing LDL cholesterol level in the blood compared to using each of these drugs individually.…”

Section: Ezetimibe (Ez) Is (3r 4s)-1-(4-flurophenyl)-3-[(3s)-3-(4-flmentioning

confidence: 99%

“…EZ and AT have been determined by some techniques including HPLC [18], HPTLC-Densitometric [19] and spectrophotometric methods [20]. On the other hand EZ and SIM have been determined in their association by HPLC [21][22][23], HPTLC-Densitometric [24] and spectrophotometric methods [25].…”

Section: Ezetimibe (Ez) Is (3r 4s)-1-(4-flurophenyl)-3-[(3s)-3-(4-flmentioning

confidence: 99%

See 2 more Smart Citations

TLC- Densitometric Method for Determination of some Cholesterol Lowering Drugs in Different Combinations

Abdelwahab¹,

El-Zeiny²,

Tohamy³

2012

J Chromat Separation Techniq

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Sensitive, selective, precise and economic TLC-Densitometric method has been developed for determination of two binary mixtures containing the antihyperlipidemic Ezetimibe (EZ) in its combination with Atorvastatin calcium (AT) [mixture I] and with Simvastatin (SIM) [mixture II].In the developed TLC-Densitometric method EZ, AT and SIM were quantitatively separated on 60F 254 silica gel plates using ethyl acetate: hexane: glacial acetic acid (5.5:4.5:0.1 by volume) as a developing system with UV detection at 254 nm. Factors affecting the chromatographic separation have been studied, moreover the method has been validated as per ICH guidelines and it has been successfully applied for determination of the studied drugs in their different dosage forms without interference from excepients. Results obtained by the developed TLCDensitometric method were statistically compared with those obtained by the reported spectrophotometric method and no significant difference was found between them.

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Section: Methods Optimizationmentioning

confidence: 99%

Section: Ezetimibe (Ez) Is (3r 4s)-1-(4-flurophenyl)-3-[(3s)-3-(4-flmentioning

confidence: 99%

See 1 more Smart Citation

TLC- Densitometric Method for Determination of some Cholesterol Lowering Drugs in Different Combinations

Abdelwahab¹,

El-Zeiny²,

Tohamy³

2012

J Chromat Separation Techniq

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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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Stability-Indicating HPTLC Method for Simultaneous Determination of Ezetimibe and Simvastatin

Cited by 39 publications

References 15 publications

TLC- Densitometric Method for Determination of some Cholesterol Lowering Drugs in Different Combinations

TLC- Densitometric Method for Determination of some Cholesterol Lowering Drugs in Different Combinations

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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