Environmental benign RP-HPLC method for the simultaneous estimation of anti-hypertensive drugs using analytical quality by design

Dharuman, Naveenarani; Lakshmi, Karunanidhi Santhana; Krishnan, Manikandan

doi:10.1080/17518253.2023.2214176

Green Chemistry Letters and Reviews

2023

DOI: 10.1080/17518253.2023.2214176

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Environmental benign RP-HPLC method for the simultaneous estimation of anti-hypertensive drugs using analytical quality by design

Naveenarani Dharuman,

Karunanidhi Santhana Lakshmi,

Manikandan Krishnan

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Cited by 11 publications

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“…10,11 The green analytical chemistry tool utilised in this study to develop a non-hazardous, and safe analytical technique to assess the quantity and quality of ACV. 12,13 The green analytical approach is evaluated using the analytical eco scale (AES), green analytical procedure index (GAPI), and the analytical greenness metric (AGREE), along with considerations for cumulative energy demand (CED) and environmental hazard safety (EHS). 14,15…”

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confidence: 99%

Green Analytical HPLC Method Development of Acyclovir Loaded Floating Raft Formulation in Spiked Rabbit Plasma

Munusamy,

Hepzhibah,

Shanmugasundharam

2024

IJDDT

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Objective: The need of this investigation is to design eco-friendly, sensitive, and precise bioanalytical high-performance liquid chromatography (HPLC) techniques that leverage green analytical tools such as green analytical procedure index (GAPI), analytical eco scale (AES), and analytical greenness metric (AGREE) to analyze ACV-spiked rabbit plasma and ACV-loaded floating raft formulation (FRF) because The literature survey revealed insufficient data for the HPLC approach to FRF. Method: Methods involving plasma spikes mirroring the in-vivo models provide insights into potential real-life scenarios and the functionality of floating raft formulations loaded with ACV. The Design Expert tool optimized critical process parameters and identified significant factors influencing the chromatographic technique. Results: The CCD was used to optimize the flow rate (0.6 mL/min) and buffer solvent ratio (99:1) for separation. The C18 column (250 X 4.6 mm) was utilized to achieve the elution of ACV. The developed method was thoroughly validated through ICH guidelines. The ACV, lower limit of detection (LLoD), and lower limit of quantitation (LLoQ) retention times were established at 2.3 minutes, 15, and 20 ng/mL, respectively. Discussion: In summary, the study demonstrated the exceptional performance sensitivity, specificity, and robustness of the bioanalytical method. The method proved highly effective in quantifying ACV in plasma samples in terms of revalidatability, transferability, reproducibility, and the product development cycle. The developed method proves that using both design of experiments (DoE) and green analytical chemistry together creates a valid, eco-friendly, and reliable way to analyze the making of an ACV-loaded floating raft formulation.

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mentioning

confidence: 99%

Green Analytical HPLC Method Development of Acyclovir Loaded Floating Raft Formulation in Spiked Rabbit Plasma

Munusamy,

Hepzhibah,

Shanmugasundharam

2024

IJDDT

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Novel Stability–Indicating Reverse‐Phase High‐Performance Liquid Chromatography Technique for Apremilast Quantification in Pharmaceuticals and Nanovesicular Systems: A Design of Experiment Approach

Sutar,

Jalalpure,

Kurangi

2024

Separation Science Plus

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An accurate and precise reverse‐phase high‐performance liquid chromatographic technique for apremilast (APR) quantification in bulk, commercial tablets, and formulated APR‐loaded nanoformulations was developed and validated by the design of the experiment approach in accordance with the International Conference of Harmonization guidelines. APR was separated by using formic acid buffer (0.1%; pH 3.2):methanol (40:60, v/v) as a solvent system with a flow rate of 1 mL/min and was detected at a wavelength of 230 nm with a retention time of 7.1 min. The central composite design was employed to optimize the developed analytical method. The calibration curve for APR was linear (r2 = 0.999), with a limit of detection of 0.5 µg/mL and a limit of quantification of 1.52 µg/mL, respectively. A recovery of APR in tablet and nanoformulation was observed in the 98.56%–99.32% range. Forced degradation studies revealed the stability of the proposed analytical method, as the APR peak remained unchanged under stress‐induced degradation experiments. Hence, the proposed chromatographic technique with a cost‐effective solvent system could be employed in the pharmaceutical industry for estimating APR in various formulations.

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Green and efficient extraction of phenolic compounds from Neem leaves using deep eutectic solvents based ultrasonic-assisted extraction

Kaur,

Schmitt-Kopplin,

Malik

2024

Food Chemistry

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Environmental benign RP-HPLC method for the simultaneous estimation of anti-hypertensive drugs using analytical quality by design

Cited by 11 publications

References 48 publications

Green Analytical HPLC Method Development of Acyclovir Loaded Floating Raft Formulation in Spiked Rabbit Plasma

Green Analytical HPLC Method Development of Acyclovir Loaded Floating Raft Formulation in Spiked Rabbit Plasma

Novel Stability–Indicating Reverse‐Phase High‐Performance Liquid Chromatography Technique for Apremilast Quantification in Pharmaceuticals and Nanovesicular Systems: A Design of Experiment Approach

Green and efficient extraction of phenolic compounds from Neem leaves using deep eutectic solvents based ultrasonic-assisted extraction

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