Elucidation of stress‐induced degradation products of mangiferin: Method development and validation

Khurana, Rajneet Kaur; Kaur, Satvinder; Kaur, Jasleen; Singh, Bhupinder

doi:10.1002/bmc.3935

Cited by 7 publications

(2 citation statements)

References 37 publications

(42 reference statements)

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“…The plasma proteins were separated from the contents by vortex mixing the contents for 45 s, followed by centrifugation at 15,000 g for 10 min. The supernatant organic fraction containing the drug was separated, diluted with mobile phase, filtered through 0.22 μm membrane filter and subjected to HPLC analysis (Beg, Chaudhary, et al, ;Beg, Sharma, Katare, Lohan, & Singh, ; Khurana, Kaur, Kaur, & Singh, ).…”

Section: Methodsmentioning

confidence: 99%

Development of a validated liquid chromatographic method for quantification of sorafenib tosylate in the presence of stress‐induced degradation products and in biological matrix employing analytical quality by design approach

Sharma

Khurana

Jain

et al. 2018

Biomedical Chromatography

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The current research work envisages an analytical quality by design-enabled development of a simple, rapid, sensitive, specific, robust and cost-effective stability-indicating reversed-phase high-performance liquid chromatographic method for determining stress-induced forced-degradation products of sorafenib tosylate (SFN). An Ishikawa fishbone diagram was constructed to embark upon analytical target profile and critical analytical attributes, i.e. peak area, theoretical plates, retention time and peak tailing. Factor screening using Taguchi orthogonal arrays and quality risk assessment studies carried out using failure mode effect analysis aided the selection of critical method parameters, i.e. mobile phase ratio and flow rate potentially affecting the chosen critical analytical attributes. Systematic optimization using response surface methodology of the chosen critical method parameters was carried out employing a two-factor-three-level-13-run, face-centered cubic design. A method operable design region was earmarked providing optimum method performance using numerical and graphical optimization. The optimum method employed a mobile phase composition consisting of acetonitrile and water (containing orthophosphoric acid, pH 4.1) at 65:35 v/v at a flow rate of 0.8 mL/min with UV detection at 265 nm using a C column. Response surface methodology validation studies confirmed good efficiency and sensitivity of the developed method for analysis of SFN in mobile phase as well as in human plasma matrix. The forced degradation studies were conducted under different recommended stress conditions as per ICH Q1A (R2). Mass spectroscopy studies showed that SFN degrades in strongly acidic, alkaline and oxidative hydrolytic conditions at elevated temperature, while the drug was per se found to be photostable. Oxidative hydrolysis using 30% H O showed maximum degradation with products at retention times of 3.35, 3.65, 4.20 and 5.67 min. The absence of any significant change in the retention time of SFN and degradation products, formed under different stress conditions, ratified selectivity and specificity of the systematically developed method.

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Section: Methodsmentioning

confidence: 99%

Development of a validated liquid chromatographic method for quantification of sorafenib tosylate in the presence of stress‐induced degradation products and in biological matrix employing analytical quality by design approach

Sharma

Khurana

Jain

et al. 2018

Biomedical Chromatography

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“…The values of intra‐ and inter‐day method precision ( n = 3) were analyzed at varied levels of concentration of RLX, namely, at 0.10 (LLOQ), 10 (low level), 20 (mid‐level), and 30 μg mL −1 (high level), for the proposed validation of the analytical method (Garg et al, 2015; Khurana et al, 2017).…”

Section: Methodsmentioning

confidence: 99%

Quality by design‐steered development and validation of analytical and bioanalytical methods for raloxifene: Application of Monte Carlo simulations and variance inflation factor

Pant

Sharma

Saini

et al. 2023

Biomedical Chromatography

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A sensitive, rapid, reproducible, and economical HPLC method is reported for the quantification of raloxifene hydrochloride employing Quality by Design (QbD) principles. Factor screening studies, employing Taguchi design, indicated buffer volume percentage and isocratic flow rate as the critical method parameters (CMPs), which significantly influence the chosen critical analytical attributes, that is, tailing factor and theoretical plate number. Method conditions were subsequently optimized using face-centered cubic design with magnitude of variance inflation factor for assessing multicollinearity among CMPs. Method operable design region (MODR) was earmarked and liquid chromatographic separation optimized using 0.05 M citrate buffer, acetonitrile, and methanol (57:40:3 v/v/v) as ggmobile phase at 0.9 mL min À1 flow rate, λ max of 280 nm, and column temperature of 40 C. Validation of the developed analytical method was accomplished as per International Council on Harmonization (ICH) guidelines confirming high levels of linearity, precision, accuracy, robustness, and sensitivity. Application of Monte Carlo simulations enabled the attainment of best plausible chromatographic resolution and corroboration of the demarcated MODR. Establishment and validation of the bioanalytical method using rat plasma samples, along with forced degradation and stability studies, corroborated the aptness of developed HPLC methods for drug quantification in the biological fluids, as well as in bulk and marketed dosage forms.

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Forced degradation studies of mangiferin and berberine by high-performance thin-layer chromatography

Mokal

Jadhav

2021

JPC-J Planar Chromat

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Elucidation of stress‐induced degradation products of mangiferin: Method development and validation

Cited by 7 publications

References 37 publications

Development of a validated liquid chromatographic method for quantification of sorafenib tosylate in the presence of stress‐induced degradation products and in biological matrix employing analytical quality by design approach

Development of a validated liquid chromatographic method for quantification of sorafenib tosylate in the presence of stress‐induced degradation products and in biological matrix employing analytical quality by design approach

Quality by design‐steered development and validation of analytical and bioanalytical methods for raloxifene: Application of Monte Carlo simulations and variance inflation factor

Forced degradation studies of mangiferin and berberine by high-performance thin-layer chromatography

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