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  • 1. Breadmore, Michael C.
    et al.
    Sänger van de Griend, Cari E.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Analytical Pharmaceutical Chemistry.
    In-capillary sample concentration in CE2014In: LC GC North America, ISSN 1527-5949, E-ISSN 1939-1889, Vol. 32, no 3, p. 174-186Article in journal (Refereed)
  • 2.
    El Deeb, Sami
    et al.
    TU Braunschweig, Inst Med & Pharmaceut Chem, D-38106 Braunschweig, Germany..
    Waetzig, Hermann
    TU Braunschweig, Inst Med & Pharmaceut Chem, D-38106 Braunschweig, Germany..
    El-Hady, Deia Abd
    Univ Jeddah, Dept Chem, Fac Sci, Jeddah, Saudi Arabia.;Assiut Univ, Dept Chem, Fac Sci, Assiut, Egypt..
    Sänger-van de Griend, Cari
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Analytical Pharmaceutical Chemistry. Kantisto BV, Baarn, Netherlands.;Univ Tasmania, Australian Ctr Res Separat Sci ACROSS, Sch Chem, Hobart, Tas, Australia..
    Scriba, Gerhard K. E.
    Univ Jena, Sch Pharm, Dept Pharmaceut Med Chem, Jena, Germany..
    Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis (2013-2015)2016In: Electrophoresis, ISSN 0173-0835, E-ISSN 1522-2683, Vol. 37, no 12, p. 1591-1608Article, review/survey (Refereed)
    Abstract [en]

    This review updates and follows-up a previous review by highlighting recent advancements regarding capillary electromigration methodologies and applications in pharmaceutical analysis. General approaches such as quality by design as well as sample injection methods and detection sensitivity are discussed. The separation and analysis of drug-related substances, chiral CE, and chiral CE-MS in addition to the determination of physicochemical constants are addressed. The advantages of applying affinity capillary electrophoresis in studying receptor-ligand interactions are highlighted. Finally, current aspects related to the analysis of biopharmaceuticals are reviewed. The present review covers the literature between January 2013 and December 2015.

  • 3. El Deeb, Sami
    et al.
    Wätzig, Hermann
    Abd El-Hady, Deia
    Albishri, Hassan M.
    Sänger - van de Griend, Cari
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Analytical Pharmaceutical Chemistry.
    Scriba, Gerhard K. E.
    Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis2014In: Electrophoresis, ISSN 0173-0835, E-ISSN 1522-2683, Vol. 35, no 1, p. 170-189Article, review/survey (Refereed)
    Abstract [en]

    Since the introduction about 30 years ago, CE techniques have gained a significant impact in pharmaceutical analysis. The present review covers recent advances and applications of CE for the analysis of pharmaceuticals. Both small molecules and biomolecules such as proteins are considered. The applications range from the determination of drug-related substances to the analysis of counterions and the determination of physicochemical parameters. Furthermore, general considerations of CE methods in pharmaceutical analysis are described.

  • 4.
    Paul, Prasanta
    et al.
    Univ Leuven, KU Leuven, Dept Pharmaceut & Pharmacol Sci, Leuven, Belgium..
    Duchateau, Tom
    Univ Leuven, KU Leuven, Dept Pharmaceut & Pharmacol Sci, Leuven, Belgium..
    Sänger - van de Griend, Cari
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Analytical Pharmaceutical Chemistry. Kantisto BV, Baarn, Netherlands..
    Adams, Erwin
    Univ Leuven, KU Leuven, Dept Pharmaceut & Pharmacol Sci, Leuven, Belgium..
    Van Schepdael, Ann
    Univ Leuven, KU Leuven, Dept Pharmaceut & Pharmacol Sci, Leuven, Belgium..
    Capillary electrophoresis with capacitively coupled contactless conductivity detection method development and validation for the determination of azithromycin, clarithromycin, and clindamycin2017In: Journal of Separation Science, ISSN 1615-9306, E-ISSN 1615-9314, Vol. 40, no 17, p. 3535-3544Article in journal (Refereed)
    Abstract [en]

    A capillary electrophoresis with capacitively coupled contactless conductivity detection based method for the assay of azithromycin, clarithromycin and clindamycin was optimized and validated in this study. A buffer solution of 20 mM 2-(N-morpholino) ethane sulfonic acid, 40 mM L-histidine and 0.6 mM cetyltrimethylammonium bromide (pH 6.39) was used for the electrophoresis. An uncoated, bare-fused silica capillary (total length 60 cm, effective length 32 cm, 75 mu m id) was used at 25 degrees C. The sample was injected hydrodynamically at 0.5 psi for 5 s. The electrophoresis was conducted at 30 kV in reverse polarity for 6 min with 3 and 2 min of in-between sodium hydroxide (0.1 M) and background electrolyte rinsing, respectively. Ammonium acetate was used as internal standard. This simple and robust method showed reasonable limit of detection and limit of quantitation for azithromycin (0.0125/0.03 mg/mL), clarithromycin (0.017/0.03 mg/mL), and clindamycin (0.038/0.06 mg/mL), with good selectivity, precision both intraday (relative standard deviation <= 1.0%) and interday (relative standard deviation < 3.7%), linearity (R-2 > 0.999) and recovery (99 - 101.7%). The method was successfully applied for the determination of azithromycin, clarithromycin and clindamycin in formulations.

  • 5.
    Prasanta, Paul
    et al.
    KU Leuven Univ Leuven, Pharmaceut Anal, Dept Pharmaceut & Pharmacol Sci, O&N2,PB 923,Herestr 49, B-3000 Leuven, Belgium.
    Van Laeken, Christophe
    KU Leuven Univ Leuven, Pharmaceut Anal, Dept Pharmaceut & Pharmacol Sci, O&N2,PB 923,Herestr 49, B-3000 Leuven, Belgium.
    Sänger-van de Griend, Cari
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Analytical Pharmaceutical Chemistry. Kantisto BV, Callenburglaan 22, NL-3742 MV Baarn, Netherlands.
    Adams, Erwin
    KU Leuven Univ Leuven, Pharmaceut Anal, Dept Pharmaceut & Pharmacol Sci, O&N2,PB 923,Herestr 49, B-3000 Leuven, Belgium.
    Van Schepdael, Ann
    KU Leuven Univ Leuven, Pharmaceut Anal, Dept Pharmaceut & Pharmacol Sci, O&N2,PB 923,Herestr 49, B-3000 Leuven, Belgium.
    CE-C4D method development and validation for the assay of ciprofloxacin2016In: Journal of Pharmaceutical and Biomedical Analysis, ISSN 0731-7085, E-ISSN 1873-264X, Vol. 129, p. 1-8Article in journal (Refereed)
    Abstract [en]

    A capillary electrophoresis method with capacitively coupled contactless conductivity detection (CE-C(4)D) has been developed, optimized and validated for the determination of ciprofloxacin. Ciprofloxacin is a member of the fluoroquinolone antibiotics with a broad spectrum bactericidal activity and recommended for complicated respiratory infections, sexually transmitted diseases, tuberculosis, bacterial diarrhea etc. Method development was conducted with major focus on the quality by design (QbD) approach. During method development, multiple buffers were tried at different ionic strength. However, the optimized method finally involved a very simple background electrolyte, monosodium citrate at a concentration of 10mM without pH adjustment. The optimized CE-C(4)D method involved an uncoated fused silica capillary (59/39cm, 50μm i.d.) and hydrodynamic sample injection at a pressure of 0.5 p.s.i. for 5s. The actual separation was conducted for 10min at normal polarity with a voltage of 20kV corresponding to 5.9μA current. LiCl (1mg/mL) was used as an internal standard. The optimized method is robust and accurate (recovery >98%) which rendered the ciprofloxacin peak within five minutes with good linearity (R(2)>0.999) in the concentration range of 0.0126-0.8mg/mL. The repeatability is expressed by percentage relative standard deviation (%RSD) of the relative peak areas (RPA) and it showed good repeatability both intra-day (<3%) and inter-day (3.1%). This method, proven to be free of matrix interference, showed that the estimated percent content of ciprofloxacin (102%) was within the official requirements. Moreover, due to its ease of use and robustness, the method should also be applicable in less well controlled laboratory environments.

  • 6.
    van Tricht, Ewoud
    et al.
    Janssen Vaccines & Prevent BV, Pharmaceut & Analyt Dev, Newtonweg 1, NL-2333 CP Leiden, Netherlands..
    Geurink, Lars
    Janssen Vaccines & Prevent BV, Pharmaceut & Analyt Dev, Newtonweg 1, NL-2333 CP Leiden, Netherlands..
    Backus, Harold
    Janssen Vaccines & Prevent BV, Pharmaceut & Analyt Dev, Newtonweg 1, NL-2333 CP Leiden, Netherlands..
    Germano, Marta
    Janssen Vaccines & Prevent BV, Pharmaceut & Analyt Dev, Newtonweg 1, NL-2333 CP Leiden, Netherlands..
    Somsen, Govert W.
    Vrije Univ Amsterdam, AIMMS Div BioMol Anal, Fac Sci, De Boelelaan 1083, NL-1081 HV Amsterdam, Netherlands..
    Sänger - van de Griend, Cari
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Analytical Pharmaceutical Chemistry. Kantisto BV, Callenburglaan 22, NL-3742 MV Baarn, Netherlands.; Univ Tasmania, Sch Phys Sci Chem, ACROSS, Hobart, Tas, Australia..
    One single, fast and robust capillary electrophoresis method for the direct quantification of intact adenovirus particles in upstream and downstream processing samples2017In: Talanta: The International Journal of Pure and Applied Analytical Chemistry, ISSN 0039-9140, E-ISSN 1873-3573, Vol. 166, p. 8-14Article in journal (Refereed)
    Abstract [en]

    During development of adenovirus-based vaccines, samples have to be analyzed in order to either monitor the production process or control the quality and safety of the product. An important quality attribute is the total concentration of intact adenoviruses, which currently is determined by quantitative polymerase chain reaction (qPCR) or anion exchange-HPLC. Capillary Electrophoresis (CE) was evaluated as alternative to the current methods with the aim to have one single method that allows reliable and fast quantification of adenovirus particles throughout the full process. Intact adenoviruses samples from downstream processing and upstream processing were analyzed directly by CE with UV-detection at 214 nm. Only the samples with high amounts of DNA required a simple sample pretreatment by benzonase. Adenovirus particles were separated from matrix components such as cell debris, residual cell DNA, and/or proteins on a PVA-coated capillary using a BGE consisting of 125 mM Tris, 338 mM tricine and 0.2% v/v polysorbate-20 at pH 7.7. Full factorial design of experiments was used for method optimization as part of the analytical quality by design (AQbD) method development approach. The method was validated for the quantification of adenoviruses on five representative samples from the manufacturing process in the range of 0.5 x10(11)-1.5 x10(11) adenovirus particles per ml (similar to 80 to 250 pmo1/1). The CE method showed intermediate precision of 7.8% RSD on concentration and an accuracy (spiked recovery) of 95-110%. CE proved highly useful for process development support and is being implemented for in-process control testing for adenovirus vaccine manufacturing.

  • 7.
    Yao, Han
    et al.
    Univ Ghent, Dept Pharmaceut Anal, Fac Pharmaceut Sci, Drug Qual & Registrat DruQuaR Grp, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
    Vandenbossche, Jana
    Univ Ghent, Dept Pharmaceut Anal, Fac Pharmaceut Sci, Drug Qual & Registrat DruQuaR Grp, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
    Sänger - van de Griend, Cari
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Analytical Science.
    Janssens, Yorick
    Univ Ghent, Dept Pharmaceut Anal, Fac Pharmaceut Sci, Drug Qual & Registrat DruQuaR Grp, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
    Fernandez, Cristina Soto
    Univ Ghent, Dept Pharmaceut Anal, Fac Pharmaceut Sci, Drug Qual & Registrat DruQuaR Grp, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
    Xu, Xiaolong
    Univ Ghent, Dept Pharmaceut Anal, Fac Pharmaceut Sci, Drug Qual & Registrat DruQuaR Grp, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
    Wynendaele, Evelien
    Univ Ghent, Dept Pharmaceut Anal, Fac Pharmaceut Sci, Drug Qual & Registrat DruQuaR Grp, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
    Somsen, Govert Willem
    Vrije Univ Amsterdam, AIMMS Res Grp BioMol Anal, Div BioAnalyt Chem, De Boelelaan 1085, NL-1081 HV Amsterdam, Netherlands.
    Haselberg, Rob
    Vrije Univ Amsterdam, AIMMS Res Grp BioMol Anal, Div BioAnalyt Chem, De Boelelaan 1085, NL-1081 HV Amsterdam, Netherlands.
    De Spiegeleer, Bart
    Univ Ghent, Dept Pharmaceut Anal, Fac Pharmaceut Sci, Drug Qual & Registrat DruQuaR Grp, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
    Development of a capillary zone electrophoresis method to quantify E. coli L-asparaginase and its acidic variants2018In: Talanta: The International Journal of Pure and Applied Analytical Chemistry, ISSN 0039-9140, E-ISSN 1873-3573, Vol. 182, p. 83-91Article in journal (Refereed)
    Abstract [en]

    A capillary zone electrophoresis (CZE) method with UV detection was developed for the quantification of the E.coli L-asparaginase (L-ASNase) and its acidic variants. During the initial method development, a variety of experimental conditions were screened. Subsequently, a Design of Experiments (DoE) was used to optimize the pH and concentration of the selected background electrolyte (BGE) containing both TRIS and boric acid. Optimization was performed taking into account both the separation efficiency of L-ASNase and its acidic variants as well as overall method robustness. A repeatable separation between E.coli L-ASNase and its acidic variants was achieved on a bare fused silica capillary in combination with a BGE consisting of both 400 mM TRIS and boric acid. The method was validated for linearity, accuracy, precision, LOD, LOQ and robustness. The recovery for L-ASNase was 97.9-104.4% with a precision RSD of 1.5-3.2%, while the recovery of impurities was 92.1-109.8% with a RSD of 1.7-4.6%. The quantification limit was 1.9% (m/m). Moreover, the CZE-UV method was applied to determine the degradation rate in the presence of ammonium bicarbonate, confirming the suitability of the method. The degraded, partially charged L-ASNase was evaluated for its in-vitro enzymatic activity showing an insignificant different enzyme activity compared to the unmodified sample.

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