Analytical quality by design approach for estimating rosuvastatin calcium in pharmaceutical formulation by green HPLC method: Ecologically evaluated and stability-indicating

Rathinam, Seetharaman; Santhana, Lakshmi Karunanidhi

doi:10.7324/japs.2021.1101119

Cited by 9 publications

(5 citation statements)

References 14 publications

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“…The major goal is to improve analytical precision while minimizing the ecological footprint. The use of few, ecologically friendly chemicals, a reduction in the production of hazardous waste, and a reduction in the amount of energy used during analysis are all required by green principles [33]. The greenness of the analytical method was determined using the Analytical Eco‐Scale and Green Analytical Procedure Index (GAPI) methodologies [34, 35].…”

Section: Resultsmentioning

confidence: 99%

Fast concurrent determination of guaifenesin and pholcodine in formulations and spiked plasma using first derivative synchronous spectrofluorimetric approach

Roshdy,

Salam,

Hadad

et al. 2024

Luminescence

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Guaifenesin and pholcodine are frequently co‐formulated in certain dosage forms. A new fast first derivative synchronous spectrofluorometric method has been used for their simultaneous analysis in mixtures. Here, first derivative synchronous spectrofluorometry enabled the successful simultaneous estimation of guaifenesin at 283 nm and pholcodine at 275 nm using a wavelength difference (Δλ) of 40 nm. The method was fully validated following International Council of Harmonization guidelines. For guaifenesin and pholcodine, linearity was determined within the corresponding ranges of 0.05–0.30 and 0.10–6.0 μg/ml. The two drugs were effectively analyzed using the developed approach in their respective formulations, and the results showed good agreement with those attained using reference methods. The method demonstrated excellent sensitivity, with detection limits down to 0.007 and 0.030 μg/ml and quantitation limits of 0.020 and 0.010 μg/ml for guaifenesin and pholcodine, respectively. Therefore, the procedure was successful in determining these drugs simultaneously in vitro in spiked plasma samples and syrup dosage form. The developed methodology also offered an environmentally friendly advantage by utilizing water as the optimal diluting solvent throughout the whole work. Different greenness approaches were investigated to ensure the method’s ecofriendly properties.

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Section: Resultsmentioning

confidence: 99%

Fast concurrent determination of guaifenesin and pholcodine in formulations and spiked plasma using first derivative synchronous spectrofluorimetric approach

Roshdy,

Salam,

Hadad

et al. 2024

Luminescence

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“…The color scale transitions from red to yellow to green based on the obtained score. [55][56][57][58] In 2022, AGREEprep, an updated version of AGREE, was developed as a soware tool to assess the environmental impact The soware computes a nal score and 10 sub-scores for each sample preparation method, utilizing user-dened weights for each criterion. These scores are presented in a circular diagram, where colors indicate the greenness level of each criterion: red for low, orange for medium-low, yellow for medium, and green for high.…”

Section: Greenness Prole Of the Proposed Methodsmentioning

confidence: 99%

Eco-friendly spectrophotometric methods for concurrent analysis of phenol, 2-aminophenol, and 4-aminophenol in ternary mixtures and water samples: assessment of environmental sustainability

Mustafa,

Mohammad,

Radha

et al. 2024

RSC Adv.

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“…The data were also subjected to 3-D response surface methodology to determine the influence of flow rate, temperature and mobile phase composition on dependent variables. [34][35] Four greenness assessment methods were applied in the presented study. In NEMI, circle symbol with four quarters was designed as a pictogram; each quarter signified a component of the method that could potentially negatively influence the environment.…”

Section: Assay Of Marketed Formulationmentioning

confidence: 99%

Eco-Friendly Stability Indicating HPLC Method for Estimation of Elbasvir and Grazoprevir by Quality by Design Approach

Bhangale,

Somwanshi,

Kotade

et al. 2023

J. Adv. Zool.

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Introduction: The pharmaceutical industry faces a significant problem as a result of the worldwide requirement to modify processes in order to comply with the green analytical chemistry (GAC) requirements. An enormous amount of organic hazardous waste is produced by high-performance liquid chromatography (HPLC), one of the methods employed the most frequently at different stages in the pharmaceutical sector. Aim: To develop analytical quality by design-aided stability indicating green high-performance liquid chromatography (HPLC) method for estimation of Elbasvir and Grazoprevir in a dosage form. Material and Methods: The critical chromatographic factors were the % of ethanol in the mobile phase, flow rate, and their overall effect on the responses like asymmetry, theoretical plates, and resolution were studied to optimize the method. Green analytical chemistry (GAC) has mainly focused on developing analytical methods that are safe for the environment. Therefore, it is imperative that the GAC principles be applied in pharmacological analysis. A rotatable central composite design was employed, and the optimized conditions for chromatographic separation were made with a run time of 5 minutes using Zorbax C18 column (4.6× 150 mm, 5 µm) with 0.1% Trifluoroacetic acid and ethanol (40:60 v/v) as components of a mobile phase, flowing at a rate of 1.0 ml/minute. Photodiode array detection was carried out at 253 nm. Results: The retention time was 1.8 min for EBS and 2.84 min for GZP. According to the ICH guidelines, the proposed method was validated and stress studies revealed that Elbasvir and Grazoprevir are prone to acidic, basic, and oxidation stress conditions. An analytical eco-scale score evaluated the greenness profile and a software-based evaluation. Conclusion: The developed HPLC method is eco-friendly and shall be adopted in the routine quality control of Elbasvir and Grazoprevir in a tablet dosage form.

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Analytical quality by design approach for estimating rosuvastatin calcium in pharmaceutical formulation by green HPLC method: Ecologically evaluated and stability-indicating

Cited by 9 publications

References 14 publications

Fast concurrent determination of guaifenesin and pholcodine in formulations and spiked plasma using first derivative synchronous spectrofluorimetric approach

Fast concurrent determination of guaifenesin and pholcodine in formulations and spiked plasma using first derivative synchronous spectrofluorimetric approach

Eco-friendly spectrophotometric methods for concurrent analysis of phenol, 2-aminophenol, and 4-aminophenol in ternary mixtures and water samples: assessment of environmental sustainability

Eco-Friendly Stability Indicating HPLC Method for Estimation of Elbasvir and Grazoprevir by Quality by Design Approach

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