Citation: | Mansi Shah, Nrupesh Patel, Nagja Tripathi, Vivek K. Vyas. Capillary electrophoresis methods for impurity profiling of drugs: A review of the past decade[J]. Journal of Pharmaceutical Analysis, 2022, 12(1): 15-28. doi: 10.1016/j.jpha.2021.06.009 |
V.K.Vyas, M. Ghate, R.D. Ukawala, Recent advances in characterization of impurities-use of hyphenated LC-MS technique, Curr. Pharm. Anal. 6(2010)299-306
|
S.S. Ahuja, Assuring quality of drugs by monitoring impurities, Adv. Drug Deliv. Rev. 59(2007)3-11
|
D. Bartos, S. Gorog, Recent advances in the impurity profiling of drugs, Curr. Pharm. Anal. 4(2008)215-230
|
Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M7(R1), in:Int. Conf. Harmon., Geneva, 2017
|
K.M. Alsante, P. Boutros, M.A. Couturier, et al., Pharmaceutical impurity identification:a case study using a multidisciplinary approach, J. Pharm. Sci. 93(2004)2296-2309
|
M.D. Argentine, P.K. Owens, B.A. Olsen, Strategies for the investigation and control of process-related impurities in drug substances, Adv. Drug Deliv. Rev. 59(2007)12-28
|
A.K. Basak, A.S. Raw, A.H. Al Hakim, et al., Pharmaceutical impurities:regulatory perspective for Abbreviated New Drug Applications, Adv. Drug Deliv. Rev. 59(2007)64-72
|
M.X. Cheng, Z.L Chen, Recent advances in screening of enzymes inhibitors based on capillary electrophoresis, J. Pharm. Anal. 8(2018)226-233
|
J. Landers, Introduction to capillary electrophoresis, Handbook of Capillary and Microchip Electrophoresis and Associated Microtechniques, Third Ed. CRC Press, 2007, pp. 1-73
|
R. Jabeen, D. Payne, J. Wiktorowicz,et al., Capillary electrophoresis and the clinical laboratory, Electrophoresis 27(2006)2413-2438
|
J.L. Felhofer, L. Blanes, C.D. Garcia, Recent developments in instrumentation for capillary electrophoresis and microchip-capillary electrophoresis, Electrophoresis 31(2010)2469-2486
|
C.Q. Niu, S.Q. Zhu, High performance capillary electrophoresis analysis for cyclosporins, Chin. J. Antibiot. 23(1998)21-23
|
A. Shallan, R. Guijt, M. Breadmore, Capillary Electrophoresis:Basic Principles, Encyclopedia of Forensic Sciences, 2nd Ed., Elsevier, Amsterdam, 2013, pp. 549-559
|
R.A. Wallingford, A.G. Ewing, Capillary zone electrophoresis with electrochemical detection in 12.7 μM diameter columns, Anal. Chem. 60(1988)1972-1975
|
D. Schmalzing, W. Nashabeh, Capillary electrophoresis based immunoassays:A critical review, Electrophoresis 18(1997)2184-2193
|
L.A. Holland, S.M. Lunte, Highlight apillary electrophoresis coupled to electrochemical detection:a review of recent advances, Anal. Commun. 35(1998)27-30
|
C.M. Boone, J.C.M. Waterval, H. Lingeman, et al., Capillary electrophoresis as a versatile tool for the bioanalysis of drugs-a review, J. Pharm. Biomed. Anal. 20(1999)831-863
|
K.D. Altria, Overview of capillary electrophoresis and capillary electrochromatography, J. Chromatogr. A. 856(1999)443-463
|
N. Anastos, N.W. Barnett, S.W. Lewis, Capillary electrophoresis for forensic drug analysis :A review, Talanta 67(2005)269-279
|
T.G. Morzunova, Capillary electrophoresis in pharmaceutical analysis (A review), Pharm. Chem. J. 40(2006)158-170
|
A.C. Otieno, S.M. Mwongela, Capillary electrophoresis-based methods for the determination of lipids:a review, Anal. Chim. Acta. 624(2008)163-174
|
L. Suntornsuk, Recent advances of capillary electrophoresis in pharmaceutical analysis, Anal. Bioanal. Chem. 398(2010)29-52
|
S.S. Bahga, J.G. Santiago, Coupling isotachophoresis and capillary electrophoresis:a review and comparison of methods, Analyst 138(2013)735-754
|
E. Sieradzka, K. Witt, H. Milnerowicz, The application of capillary electrophoresis techniques in toxicological analysis, Biomed. Chromatogr. 28(2014)1507-1513
|
R.L.C. Voeten, I.K. Ventouri, R. Haselberg, et al., Capillary electrophoresis:trends and recent advances, Anal. Chem. 90(2018)1464-1481
|
A. Stolz, K. Jooss, O. Hocker, et al., Recent advances in capillary electrophoresis-mass spectrometry:Instrumentation, methodology and applications, Electrophoresis 40(2019)79-112
|
S. Stepanova, V. Kasicka, Recent developments and applications of capillary and microchip electrophoresis in proteomics and peptidomics (2015-mid 2018), J. Sep. Sci. 42(2019)398-414
|
K. Fukushi, T. Hirokawa, A.R. Timerbaev, Recent developments of capillary electrophoresis in seawater analysis, J. Chromatogr. A1606(2019)360240
|
J.S. Torano, R. Ramautar, G. De Jong, Advances in capillary electrophoresis for the life sciences, J. Chromatogr. B 1118-1119(2019)116-136
|
A.A. Elbashir, B. Saad, A.S. Ali, et al., Determination of quinocide as impurity in primaquine tablets by capillary zone electrophoresis, Biomed. Chromatogr. 23(2009)464-471
|
M.N. El-Attug, E. Adams, J. Hoogmartens, et al., Capacitively coupled contactless conductivity detection as an alternative detection mode in CE for the analysis of kanamycin sulphate and its related substances, J. Sep. Sci. 34(2011)2448-2454
|
M.N. El-Attug, E. Adams, A. van Schepdael, Development and validation of a capillary electrophoresis method with capacitively coupled contactless conductivity detection (CE-C (4) D) for the analysis of amikacin and its related substances, Electrophoresis 33(2012)2777-2782
|
S. Orlandini, B. Pasquini, R. Gotti, et al., Analytical quality by design in the development of a cyclodextrin-modified capillary electrophoresis method for the assay of metformin and its related substances, Electrophoresis 35(2014)2538-2545
|
S. Orlandini, B. Pasquini, M. Del Bubba, et al., Quality by design in the chiral separation strategy for the determination of enantiomeric impurities:Development of a capillary electrophoresis method based on dual cyclodextrin systems for the analysis of levosulpiride, J. Chromatogr. A 1380(2015)177-185
|
S. Orlandini, B. Pasquini, C. Capriniet al., et al., Enantioseparation and impurity determination of ambrisentan using cyclodextrin-modified micellar electrokinetic chromatography:Visualizing the design space within quality by design framework, J. Chromatogr. A 1467(2016)363-371
|
M.W. Lago, M.L. Friedrich, G.D. Iop, et al., Capillary zone electrophoresis method to assay tipranavir capsules and identification of oxidation product and organic impurity by quadrupole-time of flight mass spectrometry, Talanta 181(2018)182-189
|
A.S. Fayed, M.R. Rezk, H.M. Marzouk, et al., A capillary zone electrophoresis method with multiresponse chemometric optimization for the simultaneous determination of zofenopril calcium and hydrochlorothiazide in presence of hydrochlorothiazide major impurities, J. Chromatogr. Sci. 56(2018)461-471
|
B. Pasquini, S. Orlandini, M. Villar-Navarro, et al., Chiral capillary zone electrophoresis in enantioseparation and analysis of cinacalcet impurities:Use of Quality by Design principles in method development, J. Chromatogr. A 1568(2018)205-213
|
S. Orlandini, I. Giannini, M.V. Navarro, et al., Dual CD system-modified MEEKC method for the determination of clemastine and its impurities, Electrophoresis 31(2010)3296-3304
|
S. Wongwan, G.K.E. Scriba, Impurity profiling of dexamphetamine sulfate by cyclodextrin-modified microemulsion electrokinetic chromatography, Electrophoresis 31(2010)3006-3011
|
S. Orlandini, R. Gotti, I. Giannini, et al., Development of a capillary electrophoresis method for the assay of ramipril and its impurities:an issue of cis-trans isomerization, J. Chromatogr. A 1218(2011)2611-2617
|
S. Orlandini, B. Pasquini, M. Stocchero, et al., 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(2014)200-209
|
E. Kaale, L. Hollein, U. Holzgrabe, Development and validation of a generic stability-indicating MEEKC method for five fluoroquinolone antibiotics, Electrophoresis 36(2015)2736-2744
|
S. Furlanetto, S. Orlandini, I. Giannini, et al., Pitfalls and success of experimental design in the development of a mixed MEKC method for the analysis of budesonide and its impurities, Electrophoresis 30(2009)633-643
|
K. Michalska, G. Pajchel, S. Tyski, Different sample stacking strategies for the determination of ertapenem and its impurities by micellar electrokinetic chromatography in pharmaceutical formulation, J. Chromatogr. A 1216(2009)2934-2942
|
K.M. Al Azzam, B. Saad, A. Makahleah, et al., Assay and stability-indicating micellar electrokinetic chromatography method for the simultaneous determination of valacyclovir, acyclovir and their major impurity guanine in pharmaceutical formulations, Biomed. Chromatogr. 24(2010)535-543
|
A. Doomkaew, B. Prutthiwanasan, L. Suntornsuk, Stability indicating MEKC method for the determination of gliclazide and its specified impurities, J. Pharm. Biomed. Anal. 102(2015)119-128
|
S.Q. Hu, H.J. Shi, H. Yu, et al., Solvent-modified MEKC for the enantioseparation of palonosetron hydrochloride and related enantiomeric impurities, Electrophoresis 36(2015)2762-2767
|
S. Orlandini, B. Pasquini, C. Caprini, et al., Analytical Quality by Design in pharmaceutical quality assurance:Development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities, Electrophoresis 36(2015)2642-2649
|
F. Gong, H. Yang, W. Sun, et al., Development and validation of a micellar electrokinetic capillary chromatography method for the determination of goserelin and related substances, Electrophoresis. 37(2016)623-629
|
A. Rousseau, P. Chiap, R. Ivanyi, et al., Validation of a nonaqueous capillary electrophoretic method for the enantiomeric purity determination of R-flurbiprofen using a single-isomer amino cyclodextrin derivative, J. Chromatogr. A 1204(2008)219-225
|
M.A. Tonon, P.S. Bonato, Capillary electrophoretic enantioselective determination of zopiclone and its impurities, Electrophoresis 33(2012)1606-1612
|
European Pharmacopoeia, 5th Ed., Council of Europe, France, 2019
|
U.S.P. Convention, The United States pharmacopeia:the national formulary, in:United States pharmacopeial convention, 2019
|
B.P. Commission, G.M.C.(Great Britain), G.B.M. Commission, British Pharmacopoeia, Her Majesty's Stationery Office, 2020
|
V.G. Dongre, P.P. Karmuse, P.P. Rao, et al., Development and validation of UPLC method for determination of primaquine phosphate and its impurities, J. Pharm. Biomed. Anal. 46(2008)236-242
|
B. Blanchaert, E. Poderos Jorge, P. Jankovics, et al., Assay of kanamycin A by HPLC with direct UV detection, Chromatographia 76(2013)1505-1512
|
R. V Rele, S.P. Patil, Identification, iIsolation and characterization of unknown impurity in daunorubicin hydrochloride, Chem. Sci. Trans. 3(2014)1067-1077
|
W. Bouaissi, N. Ben Hamida, Development and validation of HPLC method to quantify Zofenopril in tablet, Mediterr. J. Chem. 4(2015)271-281
|
P. Sunil Reddy, T.V. Raju, P.S. Raju, et al., Development and validation of a stability-indicating RP-UPLC method for the estimation of impurities in cinacalcet hydrochloride API and its formulation, Sci. Pharm. 83(2015)583-598
|
S. Hou, M. Hindle, P.R. Byron, A stability-indicating HPLC assay method for budesonide, J. Pharm. Biomed. Anal. 24(2001)371-380
|
R.A. Jadhav, V.K. Ahirrao, A.R. Pathan, et al., An efficient HPLC-MS Method for impurity profile of ertapenem, Chromatographia83(2020)1095-1105
|
G. Bansal, M. Singh, K.C. Jindal, Forced degradation study on gliclazide and application of validated stability-indicating HPLC-UV method in stability testing of gliclazide tablets, Chromatographia 66(2007)751-755
|
M. Vishnu Murthy, K. Srinivas, R. Kumar, et al., Development and validation of a stability-indicating LC method for determining palonosetron hydrochloride, its related compounds and degradation products using naphthalethyl stationary phase, J. Pharm. Biomed. Anal. 56(2011)429-435
|
B.M. Rao, M.K. Srinivasu, G. Sridhar, et al., A stability indicating LC method for zolmitriptan, J. Pharm. Biomed. Anal. 39(2005)503-509
|
E.K. Vijayakumar, M.A. Samel, S.B. Bhalekar, et al., A new stability indicating HPLC method for related substances in zolmitriptan, Indian J. Pharm. Sci. 72(2010)119-122
|
G.S. Holkar, M.D. Rokade, R.R. Yadav, et al., Determination of assay and peak purity evaluation of acyclovir and valacyclovir by RP-HPLC method, Int. J. Theor. Appl. Sci. 4(2012)56-65
|
P. Katakam, B. Dey, N.T. Hwisa, et al., An experimental design approach for impurity profiling of valacyclovir-related products by RP-HPLC, Sci. Pharm. 82(2014)617-630
|
J.M. Rodriguez-Nogales, M.C. Garcia, M.L. Marina, High-performance liquid chromatography and capillary electrophoresis for the analysis of maize proteins, J. Sep. Sci. 29(2006)197-210
|
C. Lechnou, Capillary Electrophoresis Used As An Alternative to HPLC For Pharmaceutical Analysis of Antifungal Agents, Thomas Jafferson University, 2008
|
S.R.K. Surapureddi, K. Ravindhranath, G.S.S. Kumar, et al., High resolution and high throughput analytical methods for d-tagatose and process related impurities using capillary electrophoresis, Anal. Biochem. 609(2020)113981
|
L. Clohs, K.M. McErlane, Comparison between capillary electrophoresis and high-performance liquid chromatography for the stereoselective analysis of carvedilol in serum, J. Pharm. Biomed. Anal. 31(2003)407-412
|
D. Lupu, G. Hancu, Achiral and chiral analysis of duloxetine by chromatographic and electrophoretic methods, a review on the separation methodologies, Biomed. Chromatogr. 35(2021), e4883
|
M.S. Aurora-Prado, M. Steppe, M.F. Tavares, et al., Comparison between capillary electrophoresis and liquid chromatography for the determination of diclofenac sodium in a pharmaceutical tablet, J. AOAC Int. 85(2002)333-340
|
M.S. Aurora Prado, M. Steppe, M.F. Tavares, et al., Comparison of capillary electrophoresis and reversed-phase liquid chromatography methodologies for determination of diazepam in pharmaceutical tablets, J. Pharm. Biomed. Anal. 37(2005)273-279
|
I. Velikinac, O. Cudina, I. Jankovic, et al., Comparison of capillary zone electrophoresis and high performance liquid chromatography methods for quantitative determination of ketoconazole in drug formulations, Farmaco. 59(2004)419-424
|
R.A. Frazier, Recent advances in capillary electrophoresis methods for food analysis, Electrophoresis 22(2001)4197-4206
|