Development and validation of a method for simultaneous densitometric analysis of simvastatin and ezetimibe as the bulk drugs and in the tablet dosage form

Dhaneshwar, Suneela; Deshpande, Pravin P.; Patil, M. B.; Vadnerkar, Gaurav; Dhaneshwar, Sunil R.

doi:10.1556/achrom.20.2008.1.6

Cited by 17 publications

(20 citation statements)

References 3 publications

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“…The literature on analytical methods for DX revealed that it has been determined by high performance liquid chromatography (HPLC) [4][5][6], high performance thin layer chromatography (HPTLC) [7,8], liquid chromatography-tandem mass spectroscopy (LC-MSMS) [9], ultraviolet (UV) spectrophotometric [10] and colorimetric methods [11,12]. Recently extractive colorimetric methods using bromocresol green, bromothymol blue and bromophenol blue as ion-paring chromogens was studied but only partially validated [11,12].…”

Section: Introductionmentioning

confidence: 99%

Facile Colorimetric Determination of Duloxetine in Formulations Using Methyl Orange as Ion-Pairing Agent

Hemalatha¹,

Ganesh²,

Peng³

et al. 2013

Trop. J. Pharm Res

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Purpose: To develop a new and fully validated ion-pair spectrophotometric method for the determination of duloxetine hydrochloride (DX). Methods: Ion-pair spectrophotometric method was employed for the determination of duloxetine hydrochloride (DX) in bulk and pharmaceutical formulations using acidic dye methyl orange (MO) as ion-pairing agent at pH 4 (phthalate buffer). The yellow ion-pair complex was extracted with chloroform

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Section: Introductionmentioning

confidence: 99%

Facile Colorimetric Determination of Duloxetine in Formulations Using Methyl Orange as Ion-Pairing Agent

Hemalatha¹,

Ganesh²,

Peng³

et al. 2013

Trop. J. Pharm Res

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“…Literature survey reveals that the methods reported for the analysis of ATV and EZE individually or combinations with other drugs include spectrophotometric (Chaudhari et al, 2007;Baldha et al, 2009;Godse et al, 2009;Nilesh et al, 2010;Rajamanickam et al, 2010) and high performance thin-layer chromatography (HPTLC) (Erturk et al, 2003;Sonawane et al, 2006;Seshachalam and Kothapally, 2008). Only one HPTLC method (Dhaneshwar et al, 2007) is reported for the simultaneous determination of ATV and EZE in tablet dosage forms, where toluene and methanol (8:2) were used as mobile phase. The mobile phase used in the reported method was not able to separate completely the ATV from the combinational tablet dosage form and hence accurate estimation of ATV was not feasible by this method in combination with EZE.…”

Section: Introductionmentioning

confidence: 99%

HPTLC method development, validation, and stress degradation studies for atorvastatin and ezetimibe in multicomponent tablet dosage form

Rajasekaran

Mani

2011

Med Chem Res

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A simple, precise, rapid, selective, and economic high performance thin-layer chromatography method has been established for simultaneous analysis of atorvastatin (ATV) and ezetimibe (EZE) in tablet dosage forms. The chromatography separation was performed on precoated silica gel 60 GF 254 plates with toluene-ethyl acetate-methanol 12:5:3 (v/v/v) as mobile phase. The plate was developed to a distance of 8.0 cm at ambient temperature. The retention factors for ATV and EZE were 0.31 and 0.57, respectively. The detection band was carried out at 254 nm. The calibration curve was linear in the concentration range of 200-1200 ng/spot for both ATV and EZE. For ATV, the recovery study results ranged from 99.44 to 99.54% with RSD value ranging from 0.067 to 0.107%. For EZE, the recovery results ranged from 98.88 to 99.00% with RSD value ranging from 0.154 to 1.756%. The assay was 99.89% for ATV and 99.84% for EZE. The calibration plots revealed a good linear relationship with r 2 = 0.9991 for ATV and 0.9992 for EZE. Both ATV and EZE were subjected to different stress conditions-acid, alkaline hydrolysis, oxidation, photo degradation, dry, and wet heat treatment-as prescribed by ICH. The degradation products were well resolved from the pure drug with significantly different R f values. The method was validated for precision, accuracy, specificity, ruggedness, and robustness.

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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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Development and validation of a method for simultaneous densitometric analysis of simvastatin and ezetimibe as the bulk drugs and in the tablet dosage form

Cited by 17 publications

References 3 publications

Facile Colorimetric Determination of Duloxetine in Formulations Using Methyl Orange as Ion-Pairing Agent

Facile Colorimetric Determination of Duloxetine in Formulations Using Methyl Orange as Ion-Pairing Agent

HPTLC method development, validation, and stress degradation studies for atorvastatin and ezetimibe in multicomponent tablet dosage form

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

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