Chemometric and Design of Experiments-Based Analytical Quality by Design and Green Chemistry Approaches to Multipurpose High-Pressure Liquid Chromatographic Method for Synchronous Estimation of Multiple Fixed-Dose Combinations of Azilsartan Medoxomil

Prajapati, Pintu; Shahi, Abhinandan; Acharya, Aneri; Shah, Shailesh

doi:10.1093/jaoacint/qsac086

Cited by 21 publications

(2 citation statements)

References 22 publications

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“…This paper refers to the application of a central composite of surface response design of expert that has the advantages of studying various variables simultaneously, in addition to optimization of HPLC conditions. Accordingly, the time and cost consumption will be decreased [ 34 – 39 ] .…”

Section: Resultsmentioning

confidence: 99%

Green analytical chemistry and experimental design: a combined approach for the analysis of zonisamide

et al. 2023

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Green analytical chemistry principles, as well as experimental design, are a combined approach adopted to develop sensitive reproducible stability indicating HPLC method for Zonisamide (ZNS) determination. The optimal conditions for three chromatographic parameters were determined using a central composite design of the response surface. Kromasil C18 column (150 mm × 4.6 mm, 5 µm) was utilized with ethanol, H2O (30:70 v/v) as a mobile phase at a flow rate of 1 mL/min at 35 °C. Good reproducibility and high sensitivity were achieved along (0.5–10 µg/mL) concentration range. In contrast, the TLC-densitometric method was performed on aluminum plates precoated with silica gel 60F254 as a stationary phase and chloroform: methanol: acetic acid (8:1.5:0.5 by volume) as a developing system. Reproducible results were obtained in the range of (2–10 μg/band). The chromatograms of HPLC and TLC were scanned at 280 nm and 240 nm, respectively. The suggested methods have been validated following ICH guidelines, and no statistically significant differences were detected between the results of the current study and the official USP method. It was also found that using experimental design implements the green concept by reducing the environmental impact. Finally, Eco-Scale, GAPI and AGREE were used to assess the environmental impacts of the suggested methods.

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Section: Resultsmentioning

confidence: 99%

Green analytical chemistry and experimental design: a combined approach for the analysis of zonisamide

et al. 2023

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“…We must come up with green ways to identify different environmental toxins because there is a growing need around the world to stop using toxic chemicals and cut down on releases that are bad for the environment. To make analytical procedures safe, dangerous solvents should be swapped out for safer ones, or waste should be eliminated [ 15 – 20 ]. BBD is a novel method for enhancing the precision of experimental outcomes.…”

Section: Introductionmentioning

confidence: 99%

Facile synthesis and eco-friendly analytical methods for concurrent estimation of selected pharmaceutical drugs in their solutions: application to quality by design, lean six sigma, and stability studies

Al-Kadhi,

Mohamed,

Ahmed

et al. 2023

BMC Chemistry

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Economical, highly robust, selective, precise, and eco-friendly RP-UPLC and spectrophotometric methods were developed and validated for the concurrent estimation of selected pharmaceutical drugs represented in ceftazidime (CFZ) and pyridine (PYD) in their solutions using Agilent Zorbax SB-C18 RRHD (50 × 2.1 mm, 1.8 μm) column at flow rate 0.3 mL/min with wavelength 254 nm. Box-Behnken design (BBD) established Response surface methodology (RSM) to achieve the optimum chromatographic condition with minimal trials conducted. Three independent variables specifically acetonitrile ratio 60–70%, pH 3–7, and temperature 25–35 °C were implemented to evaluate the influences of these variables on the responses as resolution and retention time. Desirability and overlay plots were carried out to adjust the optimal condition that achieved the shortest retention time of less than 2 min and desired resolution of more than 1.5 using a mobile phase consisting of acetonitrile: purified water (70:30, v/v) at pH 5.0 adjusted by 0.1% orthophosphoric acid with the column oven temperature 30 °C and column void volume 0.46 mL. Mean centering of ratio spectra (MCR) and ratio subtraction (RS) methods were effectively applied to resolve drugs' spectral superposition at 220 nm, 255.4 nm, 260.3 nm, and 254.6 nm for CFZ and PYD, respectively. Linearity range was accomplished for UPLC, MCR, and RS methods over the concentration range of 2–100, 1–50,3–30 and 5–30 µg/mL for CFZ and PYD, respectively with correlation coefficient > 0.999 and good recovery results within 98–102%. Six Sigma methodology was achieved using the process capability index (Cpk) to compare the suggested and USP methods showing that both are highly capable with Cpk > 1.33. The proposed method was successfully validated depending on ICH guidelines and ANOVA results and applied for the accelerated stability study. Graphical Abstract

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White analytical chemistry‐driven stability‐indicating concomitant chromatographic estimation of thiocolchicoside and aceclofenac using response surface analysis and red, green, and blue model

Prajapati¹,

Pulusu

Shah³

2023

J of Separation Science

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White analytical chemistry is a novel concept for the assessment of analytical methods on basis of its validation efficiency, greenness power, and economical efficiency. White analytical chemistry‐driven stability indicating chromatographic method has been developed for the concomitant analysis of thiocolchicoside and aceclofenac. The proposed chromatographic method has been developed using a safe and environmental‐friendly organic solvents for the concomitant stability study of thiocolchicoside and aceclofenac. The analytical risk assessment was carried out for the identification of high‐risk analytical risk factors and analytical method performance attributes. The mixture design was applied for the design of experiments‐based response surface modeling of high‐risk analytical risk factors and analytical method performance attributes. The degradation products were isolated and characterized using infrared, nuclear magnetic resonance, and mass spectral data. The proposed method was compared for its validation efficiency, greenness power, and cost‐efficiency with published chromatographic methods using the red, green, and blue models. The white score of the proposed and reported method was calculated by averaging the red, green, and blue scores of the methods. The proposed method was found to be robust, green, and economical for the concomitant stability study of thiocolchicoside and aceclofenac.

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Chemometric and Design of Experiments-Based Analytical Quality by Design and Green Chemistry Approaches to Multipurpose High-Pressure Liquid Chromatographic Method for Synchronous Estimation of Multiple Fixed-Dose Combinations of Azilsartan Medoxomil

Cited by 21 publications

References 22 publications

Green analytical chemistry and experimental design: a combined approach for the analysis of zonisamide

Green analytical chemistry and experimental design: a combined approach for the analysis of zonisamide

Facile synthesis and eco-friendly analytical methods for concurrent estimation of selected pharmaceutical drugs in their solutions: application to quality by design, lean six sigma, and stability studies

White analytical chemistry‐driven stability‐indicating concomitant chromatographic estimation of thiocolchicoside and aceclofenac using response surface analysis and red, green, and blue model

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