Development and Validation of Stability-Indicating HPLC Methods for Quantitative Determination of Pravastatin, Fluvastatin, Atorvastatin, and Rosuvastatin in Pharmaceuticals

Gomes, Fábio Pereira; García, Pedro López; Alves, João M. P.; Singh, Anil Kumar; Kedor-Hackmann, Érika Rosa Maria; Santoro, María Inés Rocha Miritello

doi:10.1080/00032710903060669

Cited by 46 publications

(22 citation statements)

References 36 publications

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“…Two stability-indicating HPLC methods for quantitative determination of pravastatin, fluvastatin, atorvastatin and rosuvastatin in pharmaceuticals were developed [124].…”

Section: Simultaneous Analysis Of Statin Drugsmentioning

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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“…Two stability-indicating HPLC methods for quantitative determination of pravastatin, fluvastatin, atorvastatin and rosuvastatin in pharmaceuticals were developed [124].…”

Section: Simultaneous Analysis Of Statin Drugsmentioning

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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“…Chromatographic methods such as HPLC with spectrophotometric detection were successfully used for the determination of inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase (18)(19)(20). Electroanalytical methods (21,22) and spectrophotometric methods were also applied (23).…”

Section: Valsartan (Val) (S)-3-methyl-2-(n-{[2'mentioning

confidence: 99%

Spectrophotometric method for simultaneous determination of valsartan and substances from the group of statins in binary mixtures

et al. 2017

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Applicability of derivative spectrophotometry for the determination of valsartan in the presence of a substance from the group of statins was checked. The obtained results indicate that the proposed method may be effective by using appropriate derivatives: for valsartan and fluvastatin -D1, D2 and D3, for valsartan and pravastatin -D1 and D3, for valsartan and atorvastatin -D2 and D3. The method was characterized by high sensitivity and accuracy. Linearity was maintained in the following ranges: 9.28-32.48 mg mL -1 for valsartan, 8.16-28.56 mg mL -1 for fluvastatin, 14.40-39.90 mg mL -1 for atorvastatin and 9.60-48.00 mg mL -1 for pravastatin. Determination coefficients were in the range of 0.989-0.999 depending on the analyte and the order of derivative. The precision of the method was high with RSD from 0.1 to 2.5 % and recovery of individual components was within the range of 100 ± 5 %. The developed method was successfully applied to the determination of valsartan combined with fluvastatin, atorvastatin and pravastatin in laboratory prepared mixtures and in pharmaceutical preparations.

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“…First derivative spectrophotometry [7] and kinetic spectrophotometric [8] determination of fluvastatin in pharmaceutical preparations have been reported. FVS have been determined by capillary electrophoresis [9] (CE), high performance liquid chromatography (HPLC) in biological fluids such as human and rat plasma [10][11][12][13][14][15][16][17]. Liquid chromatography-mass spectrometry [18][19] and gas chromatography-mass spectrometry [20] have been reported for the determination of FVS in biological fluids.…”

Section: Introductionmentioning

confidence: 99%

“…Mielcarek et al has been studied a photodegradation of fluvastatin in methanol or water, in accordance with the ICH recommendations of the first version by HPTLC [21]. Gomes et al developed the stability indicating HPLC method for determination of FVS in pharmaceutical [17]. Gomes et al studied limited stress condition like acidic, neutral, alkaline and chemical oxidative degradation was discussed [17].…”

Section: Introductionmentioning

confidence: 99%

“…Gomes et al developed the stability indicating HPLC method for determination of FVS in pharmaceutical [17]. Gomes et al studied limited stress condition like acidic, neutral, alkaline and chemical oxidative degradation was discussed [17]. Gomes et al was not studied for the specificity, peak purity or correlation between spectra of standard and test FVS in the presence of the degradation product that are likely to be present as an impurity in their formulations.…”

Section: Introductionmentioning

confidence: 99%

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Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Fluvastatin Sodium in Bulk and Capsule Dosage Form

Akabari¹,

Suhagia²,

Saralai³

et al. 2016

Eurasian J Anal Chem

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A sensitive, specific and stability-indicating reversed phase high performance liquid chromatography-diode array detection method was developed for the quantitative determination of fluvastatin sodium in the presence of its degradation products. The chromatographic separation was performed on a Phenomenex Luna C18 column (150 X 4.0 mm, 5µm) in isocratic mode using acetonitrile and 0.02M potassium phosphate buffer (50 + 50, v/v, pH 5.0 adjusted with potassium hydroxide) as the mobile phase at a flow rate of 1.0 ml/min. The quantification was performed with a photodiode array detector at 235nm based on peak area. The method showed good linearity over the concentration range of 5-40 µg/mL with a detection limit of 1.1µg/mL and quantification limit of 3.3µg/mL. The proposed LC method was used to investigate the kinetics of acidic and oxidative degradation of fluvastatin sodium. The acidic and oxidative degradation had shown an apparent first-order kinetics and rate constants were found to be 0.0191µg/mL/min and 0.0048µg/mL/min, respectively.

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Development and Validation of Stability-Indicating HPLC Methods for Quantitative Determination of Pravastatin, Fluvastatin, Atorvastatin, and Rosuvastatin in Pharmaceuticals

Cited by 46 publications

References 36 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

Spectrophotometric method for simultaneous determination of valsartan and substances from the group of statins in binary mixtures

Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Fluvastatin Sodium in Bulk and Capsule Dosage Form

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