Applying green analytical chemistry for development and validation of RP-HPLC stability indicating assay method for estimation of fenoverine in bulk and dosage form using quality by design approach

Saroj, Seema; Jairaj, Vinod; Rathod, Rajeshwari

doi:10.1080/10826076.2017.1304414

Cited by 19 publications

(6 citation statements)

References 14 publications

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“…AMGS is a semi-quantitative method for determining environmental sustainability [28]. AMGS is a combination of several metrics, including SHE (safety, health, and environmental assessment), which is used for solvent safety calculation via geometric mean, AMVI [29] (Analytical Mass Volume Intensity), which is used for calculating solvent volume waste, and CED (Cumulative Energy Demand), which is used for both instrument and solvent selection. When the required information was entered into the system, it produced a score of 49.38 (Fig.…”

Section: Eco-friendly Methods Assessmentmentioning

confidence: 99%

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Chanduluru

Sugumaran

2022

AChrom

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The current study explores a design and development of the simple, fast, green and selective novel method of UPLC to quantify pitavastatin and ezetimibe simultaneously. The combined approach of Green Analytical Method with Quality by Design-based risk assessment was done using the Ishikawa fishbone diagram followed by a rotatable central composite design used for the optimization. The optimal chromatographic separation was attained through a mobile phase of 72: 28% v/v ethanol and 0.1% orthophosphoric acid (pH 3.5), with a 0.31 mL min−1 flow rate. The developed UPLC-PDA method was sensitive and specific for pitavastatin and ezetimibe, with linearity ranging from 2 to 30, 10–150 μg mL−1 with an R2 of 0.9999 and 0.9997, respectively. The forced degradation study of stability-indicating assay results shows the degradation in respective stress conditions. The developed UPLC method was validated and found to have sensible results with good linearity, accuracy and precision. Further, the greenness was evaluated using five states of art metrics like NEMI, GAPI, AES, AMGS, and AGREE metrics and found the greenest results. Based on the results we concluded that the developed UPLC method could be efficient for the simultaneous determination of pitavastatin and ezetimibe in bulk and tablet dosage.

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Section: Eco-friendly Methods Assessmentmentioning

confidence: 99%

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Chanduluru

Sugumaran

2022

AChrom

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“…In this study, a two-level FFD (2 ) was applied to screening and identifying the influential chromatography method variables. Furthermore, the BBD was used to optimize the most important variables that actively affect the CAAs [52].…”

Section: Quality By Design (Qbd) Design Of Space and Design Of Expermentioning

confidence: 99%

Key information related to quality by design (QbD) applications in analytical methods development

Araujo¹,

Andrade²,

Babos³

et al. 2020

Braz. J. Anal. Chem.

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In this review, quality by design (QbD) initiatives are described as applications for many types of processes, such as in the pharmaceutical industry, biotechnology field, and for analytical methods development. Design space (DS) and design of experiments (DoE) provide useful results for analytical methods development and simulation of advanced processes in traditional manufacturing relationships. The three topics, QbD, DS and DoE are the best way to achieve strong and efficient industrial production.

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“…The existing literature provides various assays and related substance procedures for detecting FEN. [13][14][15] Notably, only one degradation product was studied in a hydrolytic stress study, although FEN's structure suggests the potential for two products when the amide bond undergoes hydrolysis. Additionally, structural characterization of the oxidative degradation products of FEN remains underexplored.…”

Section: Introductionmentioning

confidence: 99%

Isolation and characterization of novel degradation products in fenoverine by LC-QTOF-MS/MS, LC-MSⁿ and 2D-NMR

Raju,

Kumar,

Yesudas

et al. 2024

New J. Chem.

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Applying green analytical chemistry for development and validation of RP-HPLC stability indicating assay method for estimation of fenoverine in bulk and dosage form using quality by design approach

Cited by 19 publications

References 14 publications

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Key information related to quality by design (QbD) applications in analytical methods development

Isolation and characterization of novel degradation products in fenoverine by LC-QTOF-MS/MS, LC-MSⁿ and 2D-NMR

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Applying green analytical chemistry for development and validation of RP-HPLC stability indicating assay method for estimation of fenoverine in bulk and dosage form using quality by design approach

Cited by 19 publications

References 14 publications

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Key information related to quality by design (QbD) applications in analytical methods development

Isolation and characterization of novel degradation products in fenoverine by LC-QTOF-MS/MS, LC-MSn and 2D-NMR

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Isolation and characterization of novel degradation products in fenoverine by LC-QTOF-MS/MS, LC-MSⁿ and 2D-NMR