A Comprehensive Review on RSM-Coupled Optimization Techniques and Its Applications

Archives of Computational Methods in Engineering, Journal Year: 2023, Volume and Issue: 30(8), P. 4831 - 4853

Published: June 23, 2023

Language: Английский

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QbD-driven thymoquinone laden nanoemulsion for glaucoma management: In vitro, ex vivo, and pre-clinical evaluation

Journal of Drug Delivery Science and Technology, Journal Year: 2024, Volume and Issue: 94, P. 105493 - 105493

Published: Feb. 20, 2024

Language: Английский

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Facile synthesis and eco-friendly analytical methods for concurrent estimation of selected pharmaceutical drugs in their solutions: application to quality by design, lean six sigma, and stability studies

BMC Chemistry, Journal Year: 2023, Volume and Issue: 17(1)

Published: Oct. 10, 2023

Economical, highly robust, selective, precise, and eco-friendly RP-UPLC spectrophotometric methods were developed validated for the concurrent estimation of selected pharmaceutical drugs represented in ceftazidime (CFZ) pyridine (PYD) their solutions using Agilent Zorbax SB-C18 RRHD (50 × 2.1 mm, 1.8 μm) column at flow rate 0.3 mL/min with wavelength 254 nm. Box-Behnken design (BBD) established Response surface methodology (RSM) to achieve optimum chromatographic condition minimal trials conducted. Three independent variables specifically acetonitrile ratio 60-70%, pH 3-7, temperature 25-35 °C implemented evaluate influences these on responses as resolution retention time. Desirability overlay plots carried out adjust optimal that achieved shortest time less than 2 min desired more 1.5 a mobile phase consisting acetonitrile: purified water (70:30, v/v) 5.0 adjusted by 0.1% orthophosphoric acid oven 30 void volume 0.46 mL. Mean centering spectra (MCR) subtraction (RS) effectively applied resolve drugs' spectral superposition 220 nm, 255.4 260.3 254.6 nm CFZ PYD, respectively. Linearity range was accomplished UPLC, MCR, RS over concentration 2-100, 1-50,3-30 5-30 µg/mL respectively correlation coefficient > 0.999 good recovery results within 98-102%. Six Sigma process capability index (Cpk) compare suggested USP showing both are capable Cpk 1.33. The proposed method successfully depending ICH guidelines ANOVA accelerated stability study.

Language: Английский

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Analytical Quality by Design Assisted Optimization of RP-HPLC Method for the Estimation of Palovarotene Drug Substance and Drug Product by Box–Behnken Design

Biosciences Biotechnology Research Asia, Journal Year: 2025, Volume and Issue: 22(1), P. 313 - 324

Published: March 25, 2025

ABSTRACT: A QbD approach, with its emphasis on risk assessment and management, may result in the establishment of a more robust or rugged system. Critical quality attributes (CQAs) analytical target profile were evaluated by closely examining detailed process for QbD-based optimization parameters. RP- HPLC is considered useful than normal phase method since it versatile separating wider range compounds, due to non-polar stationary polar mobile phase, allowing better control over Rt composition, improved reproducibility accuracy compared HPLC. The current study outlines invention validation straightforward, quick, sensitive, affordable RP-HPLC approach investigating palovarotene tablet formulations. Three essential elements buffer pH, flow rate ratio MP used Box-Behnken design factor screening investigations. DOE trial version 12.0 was optimize chromatographic settings. With water Platisil C18-EP (4.6 x 250 mm, 5µm) column comprising KH2PO4 (pH 3.5): ACN (50:50 ml) v/v, 1.0 ml/min UV at 261 nm, best separation accomplished. interrelationships between MP, 3 distinct levels are described Box–Behnken experimental design. RSM plots statistical data evaluate retention duration theoretical plate responses. compliance suggested ICH recommendations. technique can also be utilized laboratories evaluation aimed Palovarotene drug material capsule formulation.

Language: Английский

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Development and Validation of a Robust RP-HPLC Method for the Simultaneous Analysis of Exemestane and Thymoquinone and Its Application to Lipid-Based Nanoformulations

ACS Omega, Journal Year: 2024, Volume and Issue: 9(28), P. 30120 - 30130

Published: July 3, 2024

The present study describes the development and validation of a simple rapid HPLC method for simultaneous quantification exemestane thymoquinone. separation both compounds was performed on 5 μ C-18 column utilizing phase A as water/methanol (45:5 v/v) B acetonitrile (50 (total ratio A/B = 40:60 in isocratic elution mode mobile at flow rate 0.8 mL/min. Further, Box–Behnken design used optimizing analytical method. proposed validated various parameters, all parameters were found to be within an acceptable range. detection drugs monitored 243 nm with retention time 5.73 6.93 min, respectively. Moreover, forced degradation studies conducted under stress conditions, relevance RP-HPLC further explored estimation from lipid-based nanoformulation. Taken together, construed efficient robust that could these agents vitro well vivo models.

Language: Английский

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Optimization of a HPLC–UV bioanalytical method using Box–Behnken design to determine the oral pharmacokinetics of neratinib maleate in Wistar rats

Biomedical Chromatography, Journal Year: 2023, Volume and Issue: 37(11)

Published: Aug. 31, 2023

The current research work reports the development and validation of a sensitive, robust reproducible bioanalytical method for quantifying neratinib maleate in rat plasma. More than 85% drug was extracted from plasma samples by protein precipitation. optimized using Box-Behnken design, response surface method. effect three critical factors, viz., pH buffer (X1 ), aqueous phase proportion mobile (X2 ) flow rate (X3 studied on two variables, retention time (Y1 United States Pharmacopoeia (USP) width (Y2 ). With highest overall desirability function value 0.943, obtained conditions were: X1 = 2.4 ± 0.1; X2 66.7 ml, X3 0.85 ml/min. Under conditions, values Y1 Y2 sample containing 1 ppm were found to be 14.1 min 0.50 0.003, respectively. Single-dose intravenous bolus (7.5 mg/kg) oral (15 pharmacokinetic studies performed determine absolute bioavailability drug. sensitive enough capture 95% eliminated body. 49.30%.

Language: Английский

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Optimization of chromatographic conditions via Box‒Behnken design in RP-HPLC-PDA method development for the estimation of folic acid and methotrexate in bulk and tablets

Heliyon, Journal Year: 2023, Volume and Issue: 9(10), P. e20282 - e20282

Published: Sept. 22, 2023

Simultaneous estimation of folic acid and methotrexate in bulk tablet dosage form by RP-HPLC-PDA was conducted via Box‒Behnken design application. Three-factor numerical values were finalized from the graphical optimization with built-in ANOVA BBD. Sharp symmetric peaks observed at 4.138 6.929 min for methotrexate, respectively. The mobile phase composition methanol 0.1% formic water a ratio 31:69 flow rate 1.1 ml/min. Both drugs detected wavelength 291 nm. developed method validated according to ICH guidelines. results validation parameters within acceptable limits. Stress stability studies have been performed under acidic, alkali, oxidation, neutral photolytic conditions. Three different brand-marketed tablets assessed (MGXT, FOLTNAX TRUXOFOL). In formulations, chromatogram percentages calculated 99.13% 99.50 MGXT, 99.17% 99.47 FOLTNAX, 99.91 100.05 TRUXOFOL.

Language: Английский

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Green analytical chemistry and quality by design: A combined approach towards simultaneous determination of Letrozole with its co-administered Zoledronic Acid for cancer patients

Journal of Pharmaceutical and Biomedical Analysis Open, Journal Year: 2024, Volume and Issue: 4, P. 100036 - 100036

Published: Aug. 3, 2024

Nowadays, breast cancer is the most affecting and globally diagnosed malignancy among women, yet Letrozole (LTZ) was considered first-line treatment as hormonal anticancer drug. Unfortunately, LTZ develops osteoporosis a main side effect which overcome by using co-administered; Zoledronic Acid (ZDA). Thus, there crucial need for this simultaneous quantification innovation, especially were no any previously reported methods regarding both drugs together. In study, an integrated framework conducted between experimental analytical quality-by-design (AQbD) approach green chemistry (GAC), emerging sensitive robust RP-HPLC method. Box-Behnken Design developed model optimizing isocratic chromatographic separation on C18 Equisil® ODS (4.6 × 250 mm, 5.0 μm) column at ambient temperature, mobile phase of 0.1 % aqueous trifluroacetic acid (pH 2.8): acetonitrile (54.5:45.5, v/v), 1.0 mL/min flow rate with PDA detection 254.0 nm 210.0 ZDA, respectively. Model statistical residual plots analysis significant normally distributed. Method fully validated per ICH guidelines, where good linearity 0.20–10.00 µg/mL in presence Tadalafil (TDF) internal standard, obtaining adequate correlation coefficients (r) values. Calculated LOD results 0.058 0.040 while calculated LOQ 0.175 0.122 The proposed method effectively applied bulk, pharmaceutical dosage forms, spiked human plasma. Statistical comparison anticipated ones performed. Greenness assessment evaluated Green Analytical Procedure Index (GAPI) (AGREE) tools; superiority achieved relative to other methods. Finally, EVG evaluation tool assessed, attained represented through its radar chart.

Language: Английский

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Quality by Design Approach for the Development and Validation of a Robust RP-HPLC Method for the Estimation of Aloe-Emodin

Current Pharmaceutical Analysis, Journal Year: 2024, Volume and Issue: 20(7), P. 500 - 513

Published: Aug. 26, 2024

Introduction/Objective: The current study examines the methodical Quality by Design (QbD) that facilitated creation of an easy-to-use, quick, affordable, and stability-indicating reversed- phase high-performance liquid chromatography (RP-HPLC) technique for efficient analysis aloe-emodin. Methods: chromatographic conditions were optimized with Expert software 11.0 version, i.e., flow rate, buffer concentration, column temperature. Results: results linearity graph show R2 = 0.9988. LOQ was 0.07949 μg/mL LOD 0.02623 μg/mL. According to ICH rules, validation parameters within allowed range. Utilizing Box–Behnken design experimental explains relationships between temperature at three distinct levels. responses monitored: retention time (Rt), tailing factor (Tf), number theoretical plates (NTPs). Conclusion: suggested approach appropriate quantitative determination may be used in clinical pharmacokinetic investigations, biopharmaceutics, accredited testing laboratories, quality control departments enterprises.

Language: Английский

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Recent applications of Analytical Quality-by-Design methodology for chromatographic analysis: A review

Chemometrics and Intelligent Laboratory Systems, Journal Year: 2024, Volume and Issue: 254, P. 105243 - 105243

Published: Oct. 10, 2024

Language: Английский

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