A comprehensive strategy in the development of a cyclodextrin-modified microemulsion electrokinetic chromatographic method for the assay of diclofenac and its impurities: Mixture-process variable experiments and quality by design

Journal of Chromatography A - Tập 1466 - Trang 189-198 - 2016
S. Orlandini1, B. Pasquini1, C. Caprini1, M. Del Bubba2, L. Squarcialupi3, V. Colotta3, S. Furlanetto1
1Department of Chemistry “U. Schiff”, University of Florence, Via U. Schiff 6, 50019 Sesto Fiorentino, Florence, Italy
2Department of Chemistry “U. Schiff”, University of Florence, Via della Lastruccia 3-13, 50019 Sesto Fiorentino, Florence, Italy
3Department of Neuroscience, Psychology, Drug Research and Child Health, Section of Pharmaceutical and Nutraceutical Sciences, University of Florence, Via U. Schiff 6, 50019 Sesto Fiorentino, Florence, Italy

Tài liệu tham khảo

Sweetman, 2005 Al-Turki, 2010, Therapeutic and toxic effects of new NSAIDS and related compounds: a review and prospective study, Int. J. Pharmacol., 6, 813, 10.3923/ijp.2010.813.825 Gan, 2010, Diclofenac: an update on its mechanism of action and safety profile, Curr. Med. Res. Opin., 26, 1715, 10.1185/03007995.2010.486301 2010, vol. 2, 1830 Vanbel, 1993, Chemometric optimization in drug analysis by HPLC: a critical evaluation of the quality criteria used in the analysis of drug purity, Chromatographia, 36, 120, 10.1007/BF02263847 Hájková, 2002, Simultaneous determination of methylparaben propylparaben, sodium diclofenac and its degradation product in a topical emulgel by reversed-phase liquid chromatography, Anal. Chim. Acta, 467, 91, 10.1016/S0003-2670(02)00131-9 Tehrani, 2002, Determination of synthetic precursors as impurities in diclofenac sodium raw material, Iran. J. Pharm. Res., 1, 51 Vignaduzzo, 2010, Experimentally designed validated HPLC simultaneous determination of pridinol and diclofenac in their combined pharmaceutical formulations, which allows limiting diclofenac related compound A, J. Liq. Chromatogr. R. T., 33, 1720, 10.1080/10826076.2010.519239 Beaulieu, 1990, Determination of diclofenac sodium and related compounds in raw materials and formulations, AOAC, 73, 698, 10.1093/jaoac/73.5.698 Kubala, 1993, A specific stability indicating HPLC method to determine diclofenac sodium in raw materials and pharmaceutical solid dosage forms, Drug Dev. Ind. Pharm., 19, 749, 10.3109/03639049309062980 Song, 2005, LC-MS identification of related substances in sodium diclofenac lozenges, Chin. J. Pharm. Anal., 25, 938 Korodi, 2012, Evaluation of a short stability-indicating HPLC method for diclofenac sodium gels, Pharmazie, 67, 980 Galmier, 2005, Identification of degradation products of diclofenac by electrospray ion trap mass spectrometry, J. Pharm. Biomed. Anal., 38, 790, 10.1016/j.jpba.2005.02.016 Kole, 2011, Stir bar sorptive extraction of diclofenac from liquid formulations: a proof of concept study, J. Pharm. Biomed. Anal., 54, 701, 10.1016/j.jpba.2010.10.025 Shaalan, 2013, Validated-stability indicating HPLC-DAD method for the simultaneous determination of diclofenac sodium and diflunisal in their combined dosage form, Sci. Pharm., 81, 713, 10.3797/scipharm.1301-24 Li, 2015, A novel two-dimensional liquid chromatographic system for the online toxicity prediction of pharmaceuticals and related substances, J. Hazard. Mater., 293, 15, 10.1016/j.jhazmat.2015.03.035 Manso, 2014, Determination of 4′-isobutylacetophenone and other transformation products of anti-inflammatory drugs in water and sludge from five wastewater treatment plants in Sweden by hollow fiber liquid phase microextraction and gas chromatography-mass spectrometry, Talanta, 125, 87, 10.1016/j.talanta.2014.02.056 Krzek, 2002, Densitometric determination of diclofenac 1-(2,6-dichlorophenyl)indolin-2-one and indolin-2-one in pharmaceutical preparations and model solutions, J. Pharm. Biomed. Anal., 28, 227, 10.1016/S0731-7085(01)00622-7 Raggi, 1990, Determination of bromine traces in sodium diclofenac, using X-ray fluorescence spectroscopy, J. Pharm. Biomed. Anal., 8, 975, 10.1016/0731-7085(90)80153-G Zucchi, 2005, SRTXRF analysis in different pharmaceutical forms of diclofenac sodium, Instrum. Sci. Technol., 33, 215, 10.1081/CI-200048078 Belal, 2015, Validated selective HPLC-DAD method for the simultaneous determination of diclofenac sodium and lidocaine hydrochloride in presence of four of their related substances and potential impurities, Acta Chromatogr., 27, 477, 10.1556/AChrom.27.2015.3.6 Tumpa, 2016, Quality by design determination of diclofenac potassium and its impurities by high-performance liquid chromatography, Anal. Lett., 49, 445, 10.1080/00032719.2015.1075131 Jin, 2000, Determination of diclofenac sodium by capillary zone electrophoresis with electrochemical detection, J. Chromatogr. A, 868, 101, 10.1016/S0021-9673(99)01149-8 Botello, 2010, Electrokinetic supercharging focusing in capillary zone electrophoresis of weakly ionizable analytes in environmental and biological samples, Electrophoresis, 31, 2964, 10.1002/elps.201000184 Fakhari, 2015, Surfactant-assisted electromembrane extraction combined with capillary electrophoresis as a novel technique for the determination of acidic drugs in biological fluids, Electrophoresis, 36, 3034, 10.1002/elps.201500268 García-Vázquez, 2016, Single-drop microextraction combined in-line with capillary electrophoresis for the determination of nonsteroidal anti-inflammatory drugs in urine samples, Electrophoresis, 37, 274, 10.1002/elps.201500373 Martínez-Algaba, 2004, Comparison between sodium dodecylsulphate and cetyltrimethylammonium bromide as mobile phases in the micellar liquid chromatography determination of non-steroidal anti- inflammatory drugs in pharmaceuticals, J. Pharm. Biomed. Anal., 36, 393, 10.1016/j.jpba.2004.06.011 Lachmann, 2012, Rapid determination of diclofenac in pharmaceutical formulations by capillary zone electrophoresis, Sci. Pharm., 80, 311, 10.3797/scipharm.1201-02 Yang, 2012, Determination of six analgesics by CE with an improved electromagnetic induction detector, Chromatographia, 75, 71, 10.1007/s10337-011-2151-y Cunha, 2013, Simultaneous determination of diclofenac and its common counter-ions in less than 1minute using capillary electrophoresis with contactless conductivity detection, Electrophoresis, 34, 1423, 10.1002/elps.201300008 El-Kommos, 2013, Selective micellar electrokinetic chromatographic method for simultaneous determination of some pharmaceutical binary mixtures containing non-steroidal anti-inflammatory drugs, J. Pharm. Anal., 3, 53, 10.1016/j.jpha.2012.07.005 Gimenes, 2013, Two new electrochemical methods for fast and simultaneous determination of codeine and diclofenac, Talanta, 116, 1026, 10.1016/j.talanta.2013.08.020 Dawod, 2009, Counter-flow electrokinetic supercharging for the determination of non-steroidal anti-inflammatory drugs in water samples, J. Chromatogr. A, 1216, 3380, 10.1016/j.chroma.2009.02.014 Maijó, 2011, An in-line SPE strategy to enhance sensitivity in CE for the determination of pharmaceutical compounds in river water samples, Electrophoresis, 32, 2114, 10.1002/elps.201100054 Villar Navarro, 2011, Capillary electrophoresis determination of nonsteroidal anti-inflammatory drugs in wastewater using hollow fiber liquid-phase microextraction, Electrophoresis, 32, 2107, 10.1002/elps.201100105 Yang, 2013, Simultaneous determination of content and related substances in diclofenac sodium injection by micelle capillary electrophoresis, Chin. J. Mod. Appl. Pharm., 33, 312 ICH Harmonised Tripartite Guideline. Pharmaceutical Development Q8(R2) (2009) International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Furlanetto, 2013, Quality by Design approach in the development of a solvent-modified micellar electrokinetic chromatography method: Finding the design space for the determination of amitriptyline and its impurities, Anal. Chim. Acta, 802, 113, 10.1016/j.aca.2013.10.005 Schmidt, 2013, Using an innovative Quality-by-Design approach for the development of a stability indicating UHPLC method for ebastine in the API and pharmaceutical formulations, J. Pharm. Biomed. Anal., 78-79, 65, 10.1016/j.jpba.2013.01.032 Jovanović, 2015, Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities, J. Pharm. Biomed. Anal., 110, 42, 10.1016/j.jpba.2015.02.046 Orlandini, 2015, Analytical Quality by Design in pharmaceutical quality assurance: Development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities, Electrophoresis, 36, 2642, 10.1002/elps.201500155 Pantović, 2015, Development of liquid chromatographic method for the analysis of dabigatran etexilate mesilate and its ten impurities supported by quality-by-design methodology, J. Pharm. Biomed. Anal., 111, 7, 10.1016/j.jpba.2015.03.009 Tol, 2016, A simultaneous determination of related substances by high performance liquid chromatography in a drug product using quality by design approach, J. Chromatogr. A, 1432, 26, 10.1016/j.chroma.2015.12.080 Orlandini, 2013, Application of quality by design to the development of analytical separation methods, Anal. Bioanal. Chem., 405, 443, 10.1007/s00216-012-6302-2 Rozet, 2013, Design spaces for analytical methods, Trends Anal. Chem., 42, 157, 10.1016/j.trac.2012.09.007 Silva, 2013, Micellar electrokinetic chromatography: A review of methodological and instrumental innovations focusing on practical aspects, Electrophoresis, 34, 141, 10.1002/elps.201200349 Orlandini, 2014, Multivariate optimization of capillary electrophoresis methods: A critical review, J. Pharm. Biomed. Anal., 87, 290, 10.1016/j.jpba.2013.04.014 Cornell, 2002 Brereton, 1990 Lewis, 1999 Furlanetto, 2006, Mixture design in the optimization of a microemulsion system for the electrokinetic chromatographic determination of ketorolac and its impurities: Method development and validation, Electrophoresis, 27, 805, 10.1002/elps.200500507 Giannini, 2009, Cyclodextrin-MEEKC for the analysis of oxybutynin and its impurities, Talanta, 80, 781, 10.1016/j.talanta.2009.07.071 Orlandini, 2010, Dual CD system-modified MEEKC method for the determination of clemastine and its impurities, Electrophoresis, 31, 3296, 10.1002/elps.201000066 Orlandini, 2011, Development of a capillary electrophoresis method for the assay of ramipril and its impurities: An issue of cis-trans isomerization, J. Chromatogr. A, 1218, 2611, 10.1016/j.chroma.2011.02.062 Anderson-Cook, 2004, Mixture and mixture-process variable experiments for pharmaceutical applications, Pharm. Stat, 3, 247, 10.1002/pst.138 Piepel, 2012, Mixture-process variable approach to optimize a microemulsion electrokinetic chromatography method for the quality control of a nutraceutical based on coenzyme Q10, Talanta, 97, 73, 10.1016/j.talanta.2012.03.064 Orlandini, 2014, An integrated quality by design and mixture-process variable approach in the development of a capillary electrophoresis method for the analysis of almotriptan and its impurities, J. Chromatogr. A, 1339, 200, 10.1016/j.chroma.2014.02.088 Goupy, 1993 Herrador, 2005, Estimation of the uncertainty of indirect measurements from the propagation of distributions by using the Monte-Carlo method: an overview, Chemom. Intell. Lab. Syst., 79, 115, 10.1016/j.chemolab.2005.04.010 ICH Harmonised Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2(R1) (2005) International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Moser, 1990, Synthesis and quantitative structure-activity relationship of diclofenac analogues, J. Med. Chem., 33, 2358, 10.1021/jm00171a008 MODDE v. 10, MKS Umetrics AB, Sweden. Kettaneh-Wold, 1992, Analysis of mixture data with partial least squares, Chemometr. Intell. Lab. Syst., 14, 57, 10.1016/0169-7439(92)80092-I Eriksson, 1998, Mixture design-design generation PLS analysis, and model usage, Chemom. Intell. Lab. Syst., 43, 1, 10.1016/S0169-7439(98)00126-9 Eriksson, 2008 ICH Harmonised Tripartite Guideline Impurities in New Drug Products Q3B(R2) (2006) International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Ermer, 2001, Validation in pharmaceutical analysis. Part I: an integrated approach, J. Pharm. Biomed. Anal., 24, 755, 10.1016/S0731-7085(00)00530-6 Pomponio, 2003, Analysis of catechins in extracts of Cistus species by microemulsion electrokinetic chromatography, J. Chromatogr. A, 990, 215, 10.1016/S0021-9673(02)02010-1 Furlanetto, 2010, Microemulsion electrokinetic chromatography: An application for the simultaneous determination of suspected fragrance allergens in rinse-off products, Talanta, 83, 72, 10.1016/j.talanta.2010.08.043 Orlandini, 2007, Development of a CZE method for the determination of mizolastine and its impurities in pharmaceutical preparations using response surface methodology, Electrophoresis, 28, 395, 10.1002/elps.200600380 Ishikawa, 1985 Atkinson, 2007