Eco-friendly based stability-indicating RP-HPLC technique for the determination of escitalopram and etizolam by employing QbD approach

Perumal, Durgadevi; Krishnan, Manikandan; Lakshmi, K. S.

doi:10.1080/17518253.2022.2127334

Cited by 14 publications

(6 citation statements)

References 25 publications

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“…Design of Experiments (DoE) is employed to systematically study the effects of CMPs on CQAs. The collected data is analyzed using statistical tools, leading to the development of a design space and optimal chromatographic conditions [13][14][15].…”

Section: Evaluation Of the Analytical Methods Employing The Qbd Approachmentioning

confidence: 99%

Quality by design‐engineered reversed‐phase high‐performance liquid chromatography method development and validation for simultaneous estimation of neomycin sulfate and beclomethasone dipropionate in bulk and pharmaceutical dosage form

Dessai,

Mannur,

Koli

et al. 2024

Separation Science Plus

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The aim of this study was to develop and validate a robust reversed‐phase high‐performance liquid chromatography (RP‐HPLC) method for the simultaneous estimation of neomycin sulfate (NEO) and beclomethasone dipropionate (BECLO) in both bulk drug and pharmaceutical dosage forms. The analysis was conducted using the Box‐Behnken design. The separation of NEO and BECLO was conducted on a Phenomenex Luna C‐18 column (4.6 × 150 mm, 5 µm), employing a mobile phase comprising a mixture of methanol and trifluoroacetic acid in a ratio of 88:12% v/v. The separation was performed at a flow rate of 0.6 mL/min. NEO and BECLO were analyzed at a wavelength of 240 nm employing a photodiode array detector. The validation of the methodology followed the guidelines outlined in the International Council for Harmonization Q2 R (1). The validation process involved assessing critical parameters such as linearity, accuracy, system suitability, precision, and robustness. The results for each parameter were found to be within the acceptable range. The results indicate that the established RP‐HPLC method can effectively be employed for the routine analysis of NEO and BECLO in bulk drug and pharmaceutical dosage forms.

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Section: Evaluation Of the Analytical Methods Employing The Qbd Approachmentioning

confidence: 99%

Quality by design‐engineered reversed‐phase high‐performance liquid chromatography method development and validation for simultaneous estimation of neomycin sulfate and beclomethasone dipropionate in bulk and pharmaceutical dosage form

Dessai,

Mannur,

Koli

et al. 2024

Separation Science Plus

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“…So our research provides how green chemistry helps in methods of development by using a green solvent in the UV spectrophotometric and RP-HPLC methods for favipiravir in bulk, and different tablet dosages followed by ICH guidelines, and the greenness profile of the developed UV spectrophotometric and RP-HPLC techniques was evaluated using Analytical Eco-scale, which proved the greenness of the method concerning solvent, chemicals, energy consumed, and waste produced. [23][24] Method A (Zero order spectrophotometric method)…”

Section: Different Methods Of Developmentmentioning

confidence: 99%

A Green Eco-friendly Analytical Method Development, Validation, and Stress Degradation Studies of Favipiravir in Bulk and Different Tablet Dosages Form by UV-spectrophotometric and RP-HPLC Methods with their Comparison by Using ANOVA and in-vitro Dissolution Studies

Chakraborty

Mondal

2023

Int J. Pharm. Investigation

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Favipiravir is an antiviral drug with significant and widespread antiviral action. Favipiravir was crucial in the contest against the COVID-19 pandemic because of how well it treated the SARS-CoV-2 virus. It is well known that contemporary pharmaceutical analysis establishes green, stability-indicating analytical procedures. The current study aimed to develop and assess UV-spectrophotometric (zero order, first order, area under the curve) and RP-HPLC methods for estimating favipiravir in its pharmaceutical dose form, comparing them using ANOVA and an in-vitro dissolution analysis. A green solvents composition of methanol, ethanol, and water (25:35:40 v/v/v) is used for analysis as a mobile phase and diluent. Method A is a simple zero-order spectrophotometric method for determining favipiravir at 236 nm, and the correlation coefficient in the linearity study was found to be 0.9962, LOD, and LOQ are 0.18 and 0.55 μg/mL. Method B is a first-order spectrophotometric method for determining favipiravir at 227 nm, and the correlation coefficient in the linearity study was found to be 0.9964, LOD, and LOQ are 0.64 and 1.96 μg/mL. Method C is an area under the curve spectrophotometric method for determining favipiravir at 230 to 243 nm, and the correlation coefficient in the linearity study was found to be 0.9986, LOD, and LOQ are 0.32 and 0.96 μg/mL. Method D is the RP-HPLC method for the determination of favipiravir at the retention time of 7.216 min, a flow rate of 0.80 mL/min, column temperature of 25°C, at 236 nm, Isocratic mode, and the correlation coefficient in the linearity study was found to be 0.9996, LOD, and LOQ are 0.52 and 1.56 μg/mL. All developed methods demonstrated good repeatability and recovery with %RSD < 2. The proposed established methods were assessed using one-way ANOVA. It was revealed that the F calculated value was lower than the F tabulated value, with no discernible variation in the assay results. Studies on stress degradation show that oxidation and acid degradation mostly impact favipiravir solutions. The Analytical Eco-scale verified that these methods are the greenest and most environmentally friendly, enabling the suggested approach to use an effective green analytical methodology to measure favipiravir extensively. Phosphate buffer (pH 6.4) was the best dissolution medium after analysis of the favipiravir dissolution study in several dissolution media.

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“…Despite this, it can be recognised that these tech techniques are flexible for greenness and lead to the future development of "green assessment" in pharmaceuticals. [32][33][34][35]. There is a sample process for the 12 stages of AGREE, number.…”

Section: Agree With Metricsmentioning

confidence: 99%

Eco-friendly based stability-indicating HPTLC technique for the determination of Escitalopram and Etizolam by employing quality by design approach

Perumal

Krishnan

Lakshmi

2024

AChrom

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The two chemical components Escitalopram (ESC) and Etizolam (ETZ) are beneficial for the health of individuals because it helps to treat anxiety. The study mainly illustrated that a green approach is essential in the medical sector with the help of “Green Analytical quality by design”. According to AQbD, the techniques of HPTLC have become eco-friendly, and decided to use “ESC” and “ETZ”. Hence, ethanol and phosphate buffer pH 3.5 adjusted with 1% “orthophosphoric acid”. After the retardation factor, the product ESC was found at 0.34 min and ETZ was found at 0.53 min. The linearity of ETZ the range varies from 300 to 1800 μg mL−1 and for ESC it varies from 100 to 600 μg mL−1. The validation parameter of R2 Values ranged from 0.9997 to 0.9994 for both ESC and ETZ. The study also demonstrated that different other methods were also useful for the medical sector to make it more convenient and eco-friendly. Some of those approaches are “GAPI”, “AGMS”, “NEMI”, and “AGREE”. The outcome of the study helped to find that the technique “HPTLC” is a green analytic design that helps to maintain the stability of the medicine and it was also approved as a quality design and also a novel approach in the pharmaceutical sector.

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Eco-friendly based stability-indicating RP-HPLC technique for the determination of escitalopram and etizolam by employing QbD approach

Cited by 14 publications

References 25 publications

Quality by design‐engineered reversed‐phase high‐performance liquid chromatography method development and validation for simultaneous estimation of neomycin sulfate and beclomethasone dipropionate in bulk and pharmaceutical dosage form

Quality by design‐engineered reversed‐phase high‐performance liquid chromatography method development and validation for simultaneous estimation of neomycin sulfate and beclomethasone dipropionate in bulk and pharmaceutical dosage form

A Green Eco-friendly Analytical Method Development, Validation, and Stress Degradation Studies of Favipiravir in Bulk and Different Tablet Dosages Form by UV-spectrophotometric and RP-HPLC Methods with their Comparison by Using ANOVA and in-vitro Dissolution Studies

Eco-friendly based stability-indicating HPTLC technique for the determination of Escitalopram and Etizolam by employing quality by design approach

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