Quality by design approach for green HPLC method development for simultaneous analysis of two thalassemia drugs in biological fluid with pharmacokinetic study

Fares, Michel Y.; Hegazy, Maha A.; El-Sayed, Ghada M.; Abdelrahman, Maha M.

doi:10.1039/d2ra00966h

Cited by 29 publications

(13 citation statements)

References 53 publications

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“…The accuracy of plasma samples ranged from 95.69% to 106.81% and 99.73% to 106.73% for the CSF sample, and 95.78 to 101.43% for brain homogenates. All the above results were within a range of 100 ± 15%, which is within the FDA standard limits [ 23 ]. The matrix effects at low, middle, and high concentrations of 5-CQA and GA are shown in Table 2 .…”

Section: Resultssupporting

confidence: 61%

A Rapid and Sensitive UHPLC–MS/MS Method for Determination of Chlorogenic Acid and Its Application to Distribution and Neuroprotection in Rat Brain

Bai

Zhou

et al. 2023

Pharmaceuticals

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Chlorogenic acid (5-CQA) is a phenolic natural product that has been reported to improve neurobehavioral disorders and brain injury. However, its pharmacokinetics and distribution in the rat brain remain unclear. In this study, we established a rapid and sensitive UHPLC–MS/MS method for the determination of 5-CQA in rat plasma, cerebrospinal fluid (CSF), and brain tissue to investigate whether it could pass through the blood–brain barrier (BBB) and its distribution in the rat brain, and a Caenorhabditis elegans (C. elegans) strain paralysis assay was used to investigate the neuroprotective effect of 5-CQA in different brain tissues. Chromatographic separation of 5-CQA and glycyrrhetinic acid (GA, used as internal standard) was completed in 0.5 min, and the full run time was maintained at 4.0 min. Methodological validation results presented a high accuracy (95.69–106.81%) and precision (RSD ≤ 8%), with a lower limit of quantification of 1.0 ng/mL. Pharmacokinetic results revealed that 5-CQA can pass through the BBB into the CSF, but the permeability of BBB to 5-CQA (ratio of mean AUC0-∞ of CSF to plasma) was only approximately 0.29%. In addition, 5-CQA can penetrate into the rat brain extensively and is distributed with different intensities in different nuclei. A C. elegans strain paralysis assay indicated that the neuroprotective effect of 5-CQA is positively correlated with its content in different brain tissues. In conclusion, our study for the first time explored the BBB pass rate and brain tissue distribution of 5-CQA administered via the tail vein by the UHPLC–MS/MS method and investigated the potential main target area of 5-CQA for neuroprotection, which could provide a certain basis for the treatment of nervous system-related diseases of 5-CQA.

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Section: Resultssupporting

confidence: 61%

A Rapid and Sensitive UHPLC–MS/MS Method for Determination of Chlorogenic Acid and Its Application to Distribution and Neuroprotection in Rat Brain

Bai

Zhou

et al. 2023

Pharmaceuticals

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“…The PBD is one of the ordinarily used designs in assessing the robustness while validating an analytical method. The key reason for its use is that the PBD only focuses on the main variables [ 24 , 35 , 36 ]. The screened factors are shown in Table 1 , while the design matrix is shown in Table 2 along with the measured and the predicted responses.…”

Section: Resultsmentioning

confidence: 99%

“…sign (PBD) is a two-level fraction factorial screening design that is used when only the main variables are concerned [23][24][25][26].…”

Section: Absorption Spectramentioning

confidence: 99%

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Application of Plackett–Burman Design for Spectrochemical Determination of the Last-Resort Antibiotic, Tigecycline, in Pure Form and in Pharmaceuticals: Investigation of Thermodynamics and Kinetics

2022

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Tigecycline (TIGC) reacts with 7,7,8,8-tetracyanoquinodimethane (TCNQ) to form a bright green charge transfer complex (CTC). The spectrum of the CTC showed multiple charge transfer bands with a major peak at 843 nm. The Plackett–Burman design (PBD) was used to investigate the process variables with the objective being set to obtaining the maximum absorbance and thus sensitivity. Four variables, three of which were numerical (temperature—Temp; reagent volume—RV; reaction time—RT) and one non-numerical (diluting solvent—DS), were studied. The maximum absorbance was achieved using a factorial blend of Temp: 25 °C, RV: 0.50 mL, RT: 60 min, and acetonitrile (ACN) as a DS. The molecular composition that was investigated using Job’s method showed a 1:1 CTC. The method’s validation was performed following the International Conference of Harmonization (ICH) guidelines. The linearity was achieved over a range of 0.5–10 µg mL−1 with the limits of detection (LOD) and quantification (LOQ) of 166 and 504 ng mL−1, respectively. The method was applicable to TIGC per se and in formulations without interferences from common additives. The application of the Benesi–Hildebrand equation revealed the formation of a stable complex with a standard Gibbs free energy change (∆G°) value of −26.42 to −27.95 kJ/mol. A study of the reaction kinetics revealed that the CTC formation could be best described using a pseudo-first-order reaction.

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“…These tools were largely based on those 12 principles. The primary factors that were found to have an impact on the greenness of chromatographic techniques were waste production, the use of nongreen or bio-accumulative solvents, and sample preparation [34,35].…”

Section: Introductionmentioning

confidence: 99%

High‐performance thin layer chromatographic method development and validation for simultaneous estimation of solifenacin succinate and silodosin using quality by design approach and greenness assessment

Lodha,

Pillai,

Kalyankar

et al. 2023

Separation Science Plus

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The current research developed a high‐performance thin layer chromatographic method based on green analytical chemistry and integrated experimental approaches of analytical quality by design for simultaneous estimation of solifenacin succinate and silodosin. The integration was planned to reduce energy and solvent usage, maximize efficacy, and minimize any negative environmental effects. Taguchi design for screening and optimization a Box–Behnken design was used. The n‐butanol:ethanol:triethylamine (6:4:0.1, v/v/v) mobile phase and ultraviolet detection at 221 nm were used to develop the method. As per International Council for Harmonization Q2(R1) specifications, the method was validated. Rf value for solifenacin succinate and silodosin was found to be 0.29 ± 0.02 and 0.58 ± 0.02 respectively. For solifenacin succinate and silodosin, the linearity was found over the concentration ranges of 500–2500 ng/band and 800–4000 ng/band. For solifenacin succinate, the limits of detection and quantification were found to be 13.00 and 39.34 ng/band, respectively, while for silodosin, they were 33.29 and 100.86 ng/band, respectively. For solifenacin succinate, the method revealed a percent recovery ranging from 98.49% to 99.50%, while for silodosin, it exhibited a range from 98.86% to 99.79%. The tools predicted greenness score to be 63 and 0.78, respectively, indicating the proposed method to be green.

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Quality by design approach for green HPLC method development for simultaneous analysis of two thalassemia drugs in biological fluid with pharmacokinetic study

Abstract: This work implements a combined experimental approach of analytical quality-by-design and green analytical chemistry to develop an HPLC method for simultaneous determination of the two thalassemia drugs, deferasirox and deferiprone in biological fluid for the first time.

Cited by 29 publications

References 53 publications

A Rapid and Sensitive UHPLC–MS/MS Method for Determination of Chlorogenic Acid and Its Application to Distribution and Neuroprotection in Rat Brain

A Rapid and Sensitive UHPLC–MS/MS Method for Determination of Chlorogenic Acid and Its Application to Distribution and Neuroprotection in Rat Brain

Application of Plackett–Burman Design for Spectrochemical Determination of the Last-Resort Antibiotic, Tigecycline, in Pure Form and in Pharmaceuticals: Investigation of Thermodynamics and Kinetics

High‐performance thin layer chromatographic method development and validation for simultaneous estimation of solifenacin succinate and silodosin using quality by design approach and greenness assessment

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