|
|
References
|
|
|
*** (2005) ICH Harmonised Tripartite Guideline: Quality Risk Management Q9. Geneva, Current Step 4 Version
|
|
|
*** (2009) ICH Harmonised Tripartite Guideline: Pharmaceutical Development Q8(R2). in: International Conference on Harmonisation, Geneva, Current Step 4 Version
|
|
|
*** (2008) ICH Harmonised Tripartite Guideline: Pharmaceutical Quality System Q10. in: International Conference on Harmonisation, Geneva, Current Step 4 Version
|
|
|
*** (2012) ICH Harmonised Tripartite Guideline: Development and Manufacture of Drug Substances Q11. in: International Conference on Harmonisation, Geneva, Current Step 4 Version
|
|
|
*** (2015) Analytical Procedures and Methods Validation for Drugs and Biologics: Guidance for Industry. Silver Spring, MD: U.S. Food and Drug Administration
|
|
  
|
Abdel-Moety, E.M., Ezzat, M., et al. (2021) A Combined Approach of Green Chemistry and Quality-by-design for Sustainable and Robust Analysis of Two Newly Introduced Pharmaceutical Formulations Treating Benign Prostate Hyperplasia. Microcheml J, 160: 105711
|
|
|
Aboushady, D., Parr, M.K., Hanafi, R.S. (2020) Quality-by-Design Is a Tool for Quality Assurance in the Assessment of Enantioseparation of a Model Active Pharmaceutical Ingredient. Pharmaceuticals, 13(11): 364
|
|
|
Ahuja, S. (2011) Overview of Modern Pharmaceutical Analysis. Sep. Sci. Technol, 10: 1-9
|
|
|
Araujo, P., Janagap, S. (2012) Doehlert Uniform Shell Designs and Chromatography. J Chromatogr B, 910: 14-21
|
|
|
Armstrong, N. (2006) Pharmaceutical Experimental Design and Interpretation. CRC Press
|
|
|
Attimarad, M., et al. (2020) Validation of Rapid RP-HPLC Method for Concurrent Quantification of Amlodipine and Celecoxib in Pure and Formulation Using an Experimental Design. Microchem J, 152: 104365
|
|
|
Attimarad, M., et al. (2020) Development and Validation of Rapid RP-HPLC and Green Second-Derivative UV Spectroscopic Methods for Simultaneous Quantification of Metformin and Remogliflozin in Formulation Using Experimental Design. Separations, 7(4): 59
|
|
|
Baczek, T. (2008) Computer-Assisted Optimization of Liquid Chromatography Separations of Drugs and Related Substances. Curr Pharm Anal, 4(3): 151-161
|
|
|
Beg, S., et al. (2017) Applications of Monte-carlo Simulation and Chemometric Techniques for Development of Bioanalytical Liquid Chromatography Method for Estimation of Rosuvastatin Calcium. J Liq Chromatogr R T, 40(18): 907-920
|
|
|
Beg, S., et al. (2015) Development and Validation of a Stability-Indicating Liquid Chromatographic Method for Estimating Olmesartan Medoxomil Using Quality by Design. J Chromatogr Sci, 53(7): 1048-1059
|
|
|
Beg, S., et al. (2016) QbD-driven Development and Validation of an Efficient Bioanalytical UPLC Method for Estimation of Olmesartan Medoxomil. J Liq Chromatogr R T, 39(13): 587-597
|
|
|
Belmir, H., Abourriche, A., Bennamara, A., Saffaj, T., Ihssane, B. (2021) Using Design Space and Response Surface Methodology for Developing a Liquid Chromatography Method for Simultaneous Determination of Five Statins in Pharmaceutical Form. Acta Chromatogr, 33(4): 345-353
|
|
|
Bezerra, M.A., et al. (2008) Response Surface Methodology (RSM) As a Tool for Optimization in Analytical Chemistry. Talanta, 76(5): 965-977
|
|
|
Bonfilio, R., et al. (2009) Multivariate Optimization and Validation of an Analytical Methodology by RP-HPLC for the Determination of Losartan Potassium in Capsules. Talanta, 80: 236-241
|
|
|
Brereton, R.G. (2003) Chemometrics-data Analysis for the Laboratory and Chemical Plant. Chichester: Wiley, 489-489
|
|
|
Chaudhari, S.R., Shirkhedkar, A.A. (2019) Design of Experiment Avenue for Development and Validation of RP-HPLC-PDA Method for Determination of Apremilast in Bulk and in In-house Tablet Formulation. J Anal Sci Tech, 10(1): 1-9
|
|
|
Czyrski, A., Sznura, J. (2019) The Application of Box-Behnken-Design in the Optimization of HPLC Separation of Fluoroquinolones. Sci Rep, 9(1): 1-10
|
|
|
Dalvi, A.V., et al. (2018) Design of Experiments-based RP - HPLC Bioanalytical Method Development for Estimation of Rufinamide in Rat Plasma and Brain and Its Application in Pharmacokinetic Study. J Chromatogr B, 1102: 74-82
|
|
|
Debrus, B., et al. (2011) Application of New Methodologies Based on Design of Experiments, Independent Component Analysis and Design Space for Robust Optimization in Liquid Chromatography. Anal Chim Acta, 691(1-2): 33-42
|
|
|
Dejaegher, B., Vander, H.Y. (2011) Experimental Designs and Their Recent Advances in Set-up, Data Interpretation, and Analytical Applications. J Pharm Biomed Sci, 56: 141-158
|
|
|
Dejaegher, B., Heyden, Y.V. (2007) Ruggedness and Robustness Testing. J Chromatogr A, 1158(1-2): 138-157
|
|
|
Deming, S.N., Morgan, S.L. (1993) Experimental Design: A Chemometric Approach. Elsevier Science, 2nd ed, 436
|
|
|
Dinç-Zor, Ş., et al. (2020) Chemometric Optimization of an HPLC Method for the Simultaneous Analysis of a Multi Component Drug Product by the Help of Central Composite Design. Microchem J, 152: 104322
|
|
|
Dragomiroiu, G., et al. (2015) The Development and Validation of a Rapid HPLC Method for Determination of Piroxicam. Farmacia, 63(1): 123-131
|
|
|
Ferreira, S.L.C., et al. (2007) Statistical Designs and Response Surface Techniques for the Optimization of Chromatographic Systems. J Chromatogr A, 1158(1-2): 2-14
|
|
|
Ganorkar, S.B., Shirkhedkar, A.A. (2017) Design of Experiments in Liquid Chromatography (HPLC) Analysis of Pharmaceuticals: Analytics, Applications, Implications and Future Prospects. Rev Anal Chem, 36(3): 1-43
|
|
|
Golabchifar, A., et al. (2011) Optimization of the Simultaneous Determination of Imatinib and Its Major Metabolite, CGP74588, in Human Plasma by a Rapid HPLC Method Using D-optimal Experimental Design. Talanta, 85(5): 2320-2329
|
|
|
Gy, S., et al. (2012) Design of Experiments as a Tool for LC-MS/MS Method Development for the Trace Analysis of the Potentially Genotoxic 4-dimethylaminopyridine Impurity in Glucocorticoids. J Pharm Biomed Anal, 70: 251-258
|
|
|
Habib, A.A., Hammad, S.F., Megahed, S.M., Kamal, A.H. (2020) Innovative Quality by Design Approach for Development of Green Micellar HPLC Method for Simultaneous Determination of Atorvastatin and Amlodipine. Chromatographia, 83(10): 1221-1231
|
|
|
Hadjmohammadi, M.R., Ebrahimi, P. (2004) Optimization of the Separation of Anticonvulsant Agents in Mixed Micellar Liquid Chromatography by Experimental Design and Regression Models. Anal Chim Acta, 516(1-2): 141-148
|
|
|
Herrero, A., et al. (2016) A New Multiresponse Optimization Approach in Combination with a D-Optimal Experimental Design for the Determination of Biogenic Amines in Fish by HPLC-FLD. Anal Chim Acta, 945: 31-38
|
|
|
Heyden, V.Y., et al. (2001) Guidance for Robustness/ruggedness Tests in Method Validation. J Pharm Biomed Sci, 24: 723-753
|
|
|
Hibbert, D.B. (2012) Experimental Design in Chromatography: A Tutorial Review. J Chromatogr B, 910: 2-13
|
|
|
Imam, S.S., et al. (2014) Optimization of Mobile Phase by 32-mixture Design for the Validation and Quantification of Risperidone in Bulk and Pharmaceutical Formulations Using RP-HPLC. Anal. Methods, 6(1): 282-288
|
|
|
Jain, A., et al. (2019) Application of Chemometric Approach for QbD-enabled Development and Validation of an RP-HPLC Method for Estimation of Methotrexate. J Liq Chromatogr R T, 42(15-16): 502-512
|
|
|
Jebali, S., et al. (2019) Application of Factorial and Doehlert Designs for the Optimization of the Simultaneous Separation and Determination of Antimigraine Drugs in Pharmaceutical Formulations by RP-HPLC-UV. Int J Anal Chem
|
|
|
Kojić-Marinković, S., Tumbas, M., Rakić, T., Jančić-Stojanović, B. (2014) Plackett-Burman design in robustness testing of liquid chromatographic method for determination of sodium-valproat. Arhiv za farmaciju, vol. 64, br. 2, str. 128-143
|
|
|
Komsta, Ł. (2018) Chemometrics in Chromatography. CRC Press
|
|
|
Lafossas, C., et al. (2019) Analysis of the Retention of Tetracyclines on Reversed-phase Columns: Chemometrics, Design of Experiments and Quantitative Structure-property Relationship (QSPR) Study for Interpretation and Optimization. Talanta, 198: 550-559
|
|
|
Leardi, R. (2009) Experimental Design in Chemistry: A Tutorial. Anal Chim Acta, 652(1-2): 161-172
|
|
|
Leardi, R. (2013) Experimental Design. in: Data Handling in Science and Technology, Elsevier, 9-53
|
|
|
Li, P., et al. (2008) Optimizing Ultraperformance Liquid Chromatographic Analysis of 10 Diterpenoid Compounds in Salvia miltiorrhiza Using Central Composite Design. J Agr Food Chem, 56(4): 1164-1171
|
|
|
Lobrutto, R., Patel, T. (2007) Method Validation. in: Kazakevich Y.; Lobrutto R. [ed.] HPLC for Pharmaceutical Scientists, John Wiley & Sons, Inc, 455-502, 1st ed
|
|
|
Maljurić, N., et al. (2020) A New Strategy for Development of Eco-friendly RP-HPLC Method Using Corona Charged Aerosol Detector and Its Application for Simultaneous Analysis of Risperidone and Its Related Impurities. Microchem J, 153: 104394
|
|
|
Maljurić, N., et al. (2018) Quantitative Structure-retention Relationship Modeling of Selected Antipsychotics and Their Impurities in Green Liquid Chromatography Using Cyclodextrin Mobile Phases. Anal Bioanal Chem, 410(10): 2533-2550
|
|
|
Mattrey, F.T., et al. (2017) Current Challenges and Future Prospects in Chromatographic Method Development for Pharmaceutical Research. TrAC Trends in Analytical Chemistry, 95: 36-46
|
|
|
Mendia, O.G., et al. (2017) Efficient Method Development and Validation for the Determination of Cardiovascular Drugs in Human Plasma by SPE-UHPLC-PDA-FLD. Chromatographia, 80(4): 605-615
|
|
|
Mitrović, M., et al. (2020) Analytical Quality by Design Development of an Ecologically Acceptable Enantioselective HPLC Method for Timolol Maleate Enantiomeric Purity Testing on Ovomucoid Chiral Stationary Phase. J Pharm Biomed Anal, 180: 113034
|
|
|
Nemutlu, E., et al. (2009) Simultaneous Multiresponse Optimization of an HPLC Method to Separate Seven Cephalosporins in Plasma and Amniotic Fluid: Application to Validation and Quantification of Cefepime, Cefixime and Cefoperazone. Talanta, 80(1): 117-126
|
|
|
Nguyet, A.N.M., Tallieu, L., Plaizier, J.V., Massart, D.L., Heyden, Y.V. (2003) Validation of an HPLC Method on Short Columns to Assay Ketoconazole and Formaldehyde in Shampoo. J Pharm Biomed Anal, 32(1): 1-19
|
|
|
Novotná, K., Havliš, J., Havel, J. (2005) Optimisation of High Performance Liquid Chromatography Separation of Neuroprotective Peptides: Fractional Experimental Designs Combined with Artificial Neural Networks. J Chromatogr A, 1096(1-2): 50-57
|
|
|
Otašević, B., et al. (2019) Comparison of AQbD and Grid Point Search Methodology in the Development of Micellar HPLC Method for the Analysis of Cilazapril and Hydrochlorothiazide Dosage Form Stability. Microchem J, 145: 655-663
|
|
|
Panda, S.S., et al. (2021) Analytical Eco-scale and Quality by Design-oriented Liquid Chromatography Method for Simultaneous Quantification of Metoprolol Succinate, Telmisartan, and Cilnidipine in Their Fixed-dose Combination. Sep Sci Plus, 4(3): 128-136
|
|
|
Panda, S.S., et al. (2020) Analytical Procedure Development: Concept to Application for Chemometry Based Ultrafast LC Estimation of Pimavanserin in Pharmaceuticals. J Liq Chromatogr R T, 43(3-4): 118-130
|
|
|
Patel, M.N., Kothari, C.S. (2016) Multivariate Approaches for Simultaneous Determination of Avanafil and Dapoxetine by UV Chemometrics and HPLC-QbD in Binary Mixtures and Pharmaceutical Product. J AOAC Int, 99(3): 649-663
|
|
|
Quiming, N.S., et al. (2008) Chromatographic Behavior of Uric Acid and Methyl Uric Acids on a Diol Column in HILIC. Chromatographia, 67(7-8): 507-515
|
|
|
Sahu, P.K., et al. (2018) An Overview of Experimental Designs in HPLC Method Development and Validation. J. Pharm. Biomed. Anal, 147: 590-611
|
|
|
Saini, S., et al. (2020) QbD-steered Development and Validation of an RP-HPLC Method for Quantification of Ferulic Acid: Rational Application of Chemometric Tools. J Chromatogr B, 1155: 122300
|
|
|
Sivakumar, T., et al. (2007) Multi-criteria Decision Making Approach and Experimental Design as Chemometric Tools to Optimize HPLC Separation of Domperidone and Pantoprazole. J Pharm Biomed Anal, 43(5): 1842-1848
|
|
|
Song, Q., Putcha, L. (2001) Quantitation of Promethazine and Metabolites in Urine Samples Using On-line Solid-phase Extraction and Column-switching. J Chromatogr B, 763(1-2): 9-20
|
|
|
Stojanović, B. (2013) Factorial-based Designs in Liquid Chromatography. Chromatographia, 76(5-6): 227-240
|
|
|
Sun, S., Su, H. (2002) Validated HPLC Method for Determination of Sennosides A and B in Senna Tablets. J Pharm. Biomed. Anal, 29(5): 881-894
|
|
|
Sylvester, B., et al. (2018) A Quality by Design (QbD) Approach to the Development of a Gradient High-performance Liquid Chromatography for the Simultaneous Assay of Curcuminoids and Doxorubicin from Long-circulating Liposomes. J Pharm Biomed Anal, 158: 395-404
|
|
|
Tome, T., et al. (2019) Development and Optimization of Liquid Chromatography Analytical Methods by Using AQbD Principles: Overview and Recent Advances. Org Process Res Dev, 23(9): 1784-1802
|
|
|
van Nederkassel, A.M., Aerts, A., Dierick, A., Massart, D.L., Vander, H.Y. (2003) Fast Separations on Monolithic Silica Columns: Method Transfer, Robustness and Column Ageing for Some Case Studies. J Pharm Biomed Anal, 32(2): 233-249
|
|
|
Vanbel, P.F., Tilquin, B.L., Schoenmakers, P.J. (1996) Criteria for Optimizing the Separation of Target Analytes in Complex Chromatograms. Chemometr Intell Lab, 35(1): 67-86
|
|
|
Vemić, A., et al. (2013) Chaotropic Agents in Liquid Chromatographic Method Development for the Simultaneous Analysis of Levodopa, Carbidopa, Entacapone and Their Impurities. J Pharm Biomed Anal, 77: 9-15
|
|
|
Vermeij, T., Edelbroek, P.M. (2007) Robust Isocratic High Performance Liquid Chromatographic Method for Simultaneous Determination of Seven Antiepileptic Drugs Including Lamotrigine, Oxcarbazepine and Zonisamide in Serum After Solid-phase Extraction. J Chromatogr B, 857(1): 40-46
|
|
|
Vogt, F.G., Kord, A.S. (2011) Development of Quality-By-Design Analytical Methods. J Pharm Sci, 100(3): 797-812
|
|
|
Vujić, Z., et al. (2012) Simultaneous Analysis of Irbesartan and Hydrochlorothiazide: An Improved HPLC Method with the Aid of a Chemometric Protocol. Molecules, 17(3): 3461-3474
|
|
|
Watson, D. (2020) Pharmaceutical Analysis 5th Ed: A Textbook for Pharmacy Students and Pharmaceutical Chemists. Edinburgh: Churchill Livingstone, 480
|
|
|
Yabré, M., et al. (2020) Development of a Green HPLC Method for the Analysis of Artesunate and Amodiaquine Impurities Using Quality by Design. J Pharm Biomed Anal, 190: 113507
|
|
|
Zhang, X., Hu, C. (2017) Application of Quality by Design Concept to Develop a Dual Gradient Elution Stability-indicating Method for Cloxacillin Forced Degradation Studies Using Combined Mixture-process Variable Models. J Chromatogr A, 1514: 44-53
|
|
|
|
|