QbD-driven development and validation of HPLC method for determination of Bisphenol A and Bis-sulphone in environmental samples

Pradhan, Rajesh; Krishna, Kowthavarapu Venkata; Wadhwa, Geetika; Taliyan, Rajeev; Khadgawat, Rajesh; Kachhawa, Garima; Singhvi, Gautam; Dubey, Sunil Kumar

doi:10.1080/03067319.2019.1629585

Cited by 10 publications

(4 citation statements)

References 20 publications

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“…The obtained chromatograms were used for the calculation of different system suitability parameters such as peak symmetry, %RSD, resolution, and theoretical plates. Moreover, the specificity study was also performed to verify different parameters like column efficiency, resolution, retention time, and peak tailing of the chromatographic system [17].…”

Section: Methodsmentioning

confidence: 99%

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Development and validation of a stability‐indicating reversed‐phase–high‐performance liquid chromatography method for quantification of 2‐[1‐hexyloxyethyl]‐2‐devinyl pyropheophorbide‐a from lipid‐polymeric hybrid nanoparticles

Pradhan

Dubey

Puri

et al. 2022

Separation Science Plus

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2‐[1‐hexyloxyethyl]‐2‐devinyl pyropheophorbide‐a is a second‐generation, lipophilic, chlorin‐based photosensitizer currently used for various types of solid cancer including breast, esophageal, neck, and head cancer, etc. The aim of the present work was to develop a sensitive and robust reversed‐phase–high‐performance liquid chromatography–ultraviolet detection method for the determination of 2‐[1‐hexyloxyethyl]‐2‐devinyl pyropheophorbide‐a to explore in vitro‐based applications including encapsulation, loading, drug release, and stability studies, and also could be utilized for the selective analysis of 2‐[1‐hexyloxyethyl]‐2‐devinyl pyropheophorbide‐a from developed lipid polymer hybrid nanoparticle. The developed reversed‐phase–high‐performance liquid chromatography–ultraviolet detection method was validated in terms of linearity, accuracy, precision, stability, and robustness as per standard guidelines. The developed method exhibited linearity ranging from 50 to 2000 ng/ml with an R2 value of 0.999. The limit of detection and limit of quantitation value of the developed method was found to be 14.03 and 42.80 ng/ml, respectively. Also, degradation studies revealed that 2‐[1‐hexyloxyethyl]‐2‐devinyl pyropheophorbide‐a degraded quickly under basic conditions compared to other stability conditions (i.e., acidic, oxidative, temperature, etc.). Furthermore, the developed drug‐loaded lipid polymer hybrid nanoparticle showed an average size of 123.03 nm (polydispersity index = 0.253) with an encapsulation efficiency of 70.23%. Cell cytotoxicity assay of lipid polymer hybrid nanoparticle showed significant cancer cell death equivalent to 2‐fold higher than the free drug. In conclusion, the developed reversed‐phase–high‐performance liquid chromatography–ultraviolet detection analytical method was found to be sensitive and reliable for the determination of free 2‐[1‐hexyloxyethyl]‐2‐devinyl pyropheophorbide‐a and 2‐[1‐hexyloxyethyl]‐2‐devinyl pyropheophorbide‐a content in loaded lipid polymer hybrid nanoparticle. Thereby, opening the avenues for future research to explore the detailed physiochemical and formulation designing for the 2‐[1‐hexyloxyethyl]‐2‐devinyl pyropheophorbide‐a.

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Section: Methodsmentioning

confidence: 99%

“…Consequently, pH was also determined with two different values (3.8 and 4.2) instead of the optimized value that is, pH 4.0 at the flow rate of 1 ml/min. The %RSD of robustness testing under these conditions was calculated as per regulatory guidelines [17].…”

Section: Robustnessmentioning

confidence: 99%

Development and validation of a stability‐indicating reversed‐phase–high‐performance liquid chromatography method for quantification of 2‐[1‐hexyloxyethyl]‐2‐devinyl pyropheophorbide‐a from lipid‐polymeric hybrid nanoparticles

Pradhan

Dubey

Puri

et al. 2022

Separation Science Plus

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“…The quality by design (QbD) model emphasizes a systemic approach in the development of pharmaceutical products. This approach starts with predefined specifications anchored on the product, process knowledge, and process control to assure the quality of the finished product [ 27 , 28 ]. In the present study, formulation variables were investigated using a QbD-based approach.…”

Section: Introductionmentioning

confidence: 99%

Dasatinib-Loaded Topical Nano-Emulgel for Rheumatoid Arthritis: Formulation Design and Optimization by QbD, In Vitro, Ex Vivo, and In Vivo Evaluation

et al. 2023

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The current study aimed to develop a topical emulgel of dasatinib (DTB) for rheumatoid arthritis (RA) treatment to reduce systemic side effects. The quality by design (QbD) approach was employed to optimize DTB-loaded nano-emulgel using a central composite design (CCD). Emulgel was prepared using the hot emulsification method, and then the particle size (PS) was reduced using the homogenization technique. The PS and % entrapment efficiency (% EE) were found to be 172.53 ± 3.33 nm (0.160 ± 0.014 PDI) and 95.11 ± 0.16%, respectively. The nano-emulsion (CF018 emulsion) in vitro drug release profile showed sustained release (SR) up to 24 h. MTT assay results from an in vitro cell line study revealed that formulation excipients had no effect, whereas emulgel showed a high degree of internalization. Furthermore, emulgel treatment significantly reduced LPS-induced TNF-α production in RAW 264.7 cells. The spherical shape was depicted in FESEM images of optimized nano-emulgel (CF018 emulgel) formulation. Ex vivo skin permeation was significantly increased when compared to the free drug-loaded gel (FDG). In vivo data revealed that the optimized CF018 emulgel is a non-irritant and is safe. In terms of paw swelling, the FCA-induced arthritis model demonstrated that the CF018 emulgel reduced paw swelling percentage compared to adjuvant-induced arthritis (AIA) control group. Following clinical testing in the near future, the designed preparation could be a viable alternative treatment for RA.

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“…Industrialization and urbanization have led to the entry of several hazardous compounds into the natural environment. These mixtures of chemicals are endocrinedisrupting compounds (EDCs) that have the ability to interfere with the normal physiology of the endocrine system [1,2]. EDCs are dangerous xenobiotics that have numerous unwanted health effects in humans as well as animals.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous estimation of methyl paraben, propyl paraben, and Bisphenol A in the plasma of Indian pregnant women using liquid chromatography–tandem mass spectrometry

Pradhan

Mishra

Dubey

et al. 2023

Separation Science Plus

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A selective, rapid, and novel bioanalytical method was developed for the simultaneous determination of methyl paraben, propyl paraben, and Bisphenol A in human plasma with a calibration curve range of 1–100 ng/ml. This method included protein precipitation to ensure extraction along with clean‐up of the complex biometrics. The Chromatographic separation was done using an AccucoreTM aQ liquid chromatography column (Dim. 100×3, particle size: 2.6 µm) with the mobile phase of a mixture consisting of 0.1% formic acid in water: 0.1% formic acid in acetonitrile (03:97, v/v) at a flow rate of 0.300 ml/min. The developed liquid chromatography–tandem mass spectrometry method was further validated utilizing the United States Food and Drug Administration guidelines and all the validation requirements were found to be satisfactory. This proposed method was later successfully utilized to determine the level of the three endocrine‐disrupting compounds in the plasma samples obtained from Indian pregnant women. The results suggest that these women might have been exposed to parabens and Bisphenol A from the use of products such as pharmaceuticals, cosmetics, processed food, and the environment.

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QbD-driven development and validation of HPLC method for determination of Bisphenol A and Bis-sulphone in environmental samples

Cited by 10 publications

References 20 publications

Development and validation of a stability‐indicating reversed‐phase–high‐performance liquid chromatography method for quantification of 2‐[1‐hexyloxyethyl]‐2‐devinyl pyropheophorbide‐a from lipid‐polymeric hybrid nanoparticles

Development and validation of a stability‐indicating reversed‐phase–high‐performance liquid chromatography method for quantification of 2‐[1‐hexyloxyethyl]‐2‐devinyl pyropheophorbide‐a from lipid‐polymeric hybrid nanoparticles

Dasatinib-Loaded Topical Nano-Emulgel for Rheumatoid Arthritis: Formulation Design and Optimization by QbD, In Vitro, Ex Vivo, and In Vivo Evaluation

Simultaneous estimation of methyl paraben, propyl paraben, and Bisphenol A in the plasma of Indian pregnant women using liquid chromatography–tandem mass spectrometry

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