메뉴 건너뛰기




Volumn 84, Issue , 2013, Pages 41-47

Selective determination of potential impurities in an active pharmaceutical ingredient using HPLC-SPE-HPLC

Author keywords

Impurity; Multi dimensional HPLC; Selective determination; Solid phase extraction; Synthetic intermediate

Indexed keywords

DIMETHYL SULFOXIDE;

EID: 84879559442     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2013.05.033     Document Type: Article
Times cited : (18)

References (39)
  • 1
    • 0012840366 scopus 로고    scopus 로고
    • ICH Q3A (R), International Committee for Harminization (ICH)
    • International Committee for Harminization (ICH) Impurities in New Drug Substances 2002, ICH Q3A (R).
    • (2002) Impurities in New Drug Substances
  • 2
    • 38549168121 scopus 로고    scopus 로고
    • ICH Q3B (R2), International Committee for Harminization (ICH)
    • International Committee for Harminization (ICH) Impurities in New Drug Products 2006, ICH Q3B (R2).
    • (2006) Impurities in New Drug Products
  • 6
    • 79955468501 scopus 로고    scopus 로고
    • Strategies for the identification, control and determination of genotoxic impurities in drug substances: a pharmaceutical industry perspective
    • Raman N.V.V.S.S., Prasad A.V.S.S., Ratnakar Reddy K. Strategies for the identification, control and determination of genotoxic impurities in drug substances: a pharmaceutical industry perspective. J. Pharm. Biomed. Anal. 2011, 55:662.
    • (2011) J. Pharm. Biomed. Anal. , vol.55 , pp. 662
    • Raman, N.V.V.S.S.1    Prasad, A.V.S.S.2    Ratnakar Reddy, K.3
  • 8
    • 85047681851 scopus 로고    scopus 로고
    • Reichardt's dye and its reactions with the alkylating agents 4-chloro-1-butanol, ethyl methanesulfonate, 1-bromobutane and Fast Red B - a potentially useful reagent for the detection of genotoxic impurities in pharmaceuticals
    • Corrigan D.K., Whitcombe M.J., McCrossen S., Piletsky S. Reichardt's dye and its reactions with the alkylating agents 4-chloro-1-butanol, ethyl methanesulfonate, 1-bromobutane and Fast Red B - a potentially useful reagent for the detection of genotoxic impurities in pharmaceuticals. J. Pharm. Pharmacol. 2009, 61:533.
    • (2009) J. Pharm. Pharmacol. , vol.61 , pp. 533
    • Corrigan, D.K.1    Whitcombe, M.J.2    McCrossen, S.3    Piletsky, S.4
  • 9
    • 65949108606 scopus 로고    scopus 로고
    • Approaches to assessment, testing decisions, and analytical determination of genotoxic impurities in drug substances
    • Pierson D.A., Olsen B.A., Robbins D.K., DeVries K.M., Varie D.L. Approaches to assessment, testing decisions, and analytical determination of genotoxic impurities in drug substances. Org. Process Res. Dev. 2009, 13:285.
    • (2009) Org. Process Res. Dev. , vol.13 , pp. 285
    • Pierson, D.A.1    Olsen, B.A.2    Robbins, D.K.3    DeVries, K.M.4    Varie, D.L.5
  • 10
    • 72749101941 scopus 로고    scopus 로고
    • Recent advances in trace analysis of pharmaceutical genotoxic impurities
    • Liu D.Q., Sun M., Kord A.S. Recent advances in trace analysis of pharmaceutical genotoxic impurities. J. Pharm. Biomed. Anal. 2009, 51:999.
    • (2009) J. Pharm. Biomed. Anal. , vol.51 , pp. 999
    • Liu, D.Q.1    Sun, M.2    Kord, A.S.3
  • 11
    • 36849014367 scopus 로고    scopus 로고
    • Control and analysis of alkyl esters of alkyl and aryl sulfonic acids in novel active pharmaceutical ingredients (APIs)
    • Elder D.P., Teasdale A., Lipczynski A.M. Control and analysis of alkyl esters of alkyl and aryl sulfonic acids in novel active pharmaceutical ingredients (APIs). J. Pharm. Biomed. Anal. 2008, 46:1.
    • (2008) J. Pharm. Biomed. Anal. , vol.46 , pp. 1
    • Elder, D.P.1    Teasdale, A.2    Lipczynski, A.M.3
  • 12
    • 35548997155 scopus 로고    scopus 로고
    • An impact analysis of the application of the threshold of toxicological concern concept to pharmaceuticals
    • Delaney E.J. An impact analysis of the application of the threshold of toxicological concern concept to pharmaceuticals. Regul. Toxicol. Pharmacol. 2007, 49:107.
    • (2007) Regul. Toxicol. Pharmacol. , vol.49 , pp. 107
    • Delaney, E.J.1
  • 13
    • 67349271594 scopus 로고    scopus 로고
    • Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process
    • Liu D.Q., Chen T.K., McGuire M.A., Kord A.S. Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process. J. Pharm. Biomed. Anal. 2009, 50:144.
    • (2009) J. Pharm. Biomed. Anal. , vol.50 , pp. 144
    • Liu, D.Q.1    Chen, T.K.2    McGuire, M.A.3    Kord, A.S.4
  • 14
    • 77955401057 scopus 로고    scopus 로고
    • A systematic method development strategy for determination of pharmaceutical genotoxic impurities
    • Sun M., Liu D.Q., Kord A.S. A systematic method development strategy for determination of pharmaceutical genotoxic impurities. Org. Process Res. Dev. 2010, 14:977.
    • (2010) Org. Process Res. Dev. , vol.14 , pp. 977
    • Sun, M.1    Liu, D.Q.2    Kord, A.S.3
  • 15
    • 0000745766 scopus 로고
    • Determination limits and distribution function of ultraviolet absorbing substances in liquid chromatographic analysis of plant extracts
    • Nagels L.J., Creten W.L., Vanpeperstraete P.M. Determination limits and distribution function of ultraviolet absorbing substances in liquid chromatographic analysis of plant extracts. Anal. Chem. 1983, 55:216.
    • (1983) Anal. Chem. , vol.55 , pp. 216
    • Nagels, L.J.1    Creten, W.L.2    Vanpeperstraete, P.M.3
  • 16
    • 72749101941 scopus 로고    scopus 로고
    • Recent advances in trace analysis of pharmaceutical genotoxic impurities
    • Liu D.Q., Sun M., Kord A.S. Recent advances in trace analysis of pharmaceutical genotoxic impurities. J. Pharm. Biomed. Anal. 2010, 51:999.
    • (2010) J. Pharm. Biomed. Anal. , vol.51 , pp. 999
    • Liu, D.Q.1    Sun, M.2    Kord, A.S.3
  • 17
    • 84866264492 scopus 로고    scopus 로고
    • Method development and validation study for quantitative determination of 2-chloromethyl-3,4-dimethoxy pyridine hydrochloride a genotoxic impurity in pantoprazole active pharmaceutical ingredient (API) by LC/MS/MS
    • Venugopal N., Vijaya B.R.A., Gangadhar R.K., Madhavi V., Madhavi G. Method development and validation study for quantitative determination of 2-chloromethyl-3,4-dimethoxy pyridine hydrochloride a genotoxic impurity in pantoprazole active pharmaceutical ingredient (API) by LC/MS/MS. J. Pharm. Biomed. Anal. 2012, 70:592.
    • (2012) J. Pharm. Biomed. Anal. , vol.70 , pp. 592
    • Venugopal, N.1    Vijaya, B.R.A.2    Gangadhar, R.K.3    Madhavi, V.4    Madhavi, G.5
  • 18
    • 84866240030 scopus 로고    scopus 로고
    • 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
    • Szekely G., Henriques B., Gil M., Ramos A., Alvarez C. 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. 2012, 70:251.
    • (2012) J. Pharm. Biomed. Anal. , vol.70 , pp. 251
    • Szekely, G.1    Henriques, B.2    Gil, M.3    Ramos, A.4    Alvarez, C.5
  • 19
    • 84865105313 scopus 로고    scopus 로고
    • A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products
    • Singh S., Handa T., Narayanam M., Sahu A., Junwal M., Shah R.P. A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products. J. Pharm. Biomed. Anal. 2012, 69:148.
    • (2012) J. Pharm. Biomed. Anal. , vol.69 , pp. 148
    • Singh, S.1    Handa, T.2    Narayanam, M.3    Sahu, A.4    Junwal, M.5    Shah, R.P.6
  • 20
    • 23944435696 scopus 로고    scopus 로고
    • Development and validation of a sensitive GC-MS method for the determination of trace levels of an alkylating reagent in a β-lactam active pharmaceutical ingredient
    • Li H., Sluggett G.W. Development and validation of a sensitive GC-MS method for the determination of trace levels of an alkylating reagent in a β-lactam active pharmaceutical ingredient. J. Pharm. Biomed. Anal. 2005, 39:486.
    • (2005) J. Pharm. Biomed. Anal. , vol.39 , pp. 486
    • Li, H.1    Sluggett, G.W.2
  • 22
    • 65949092783 scopus 로고    scopus 로고
    • Low level determination of 4-amino-2-ethoxy-cinnamic acid and its ethyl ester in a drug substance and its formulation prototypes by HPLC-UV-DAD
    • Soman A., Jacob S., Swanek F. Low level determination of 4-amino-2-ethoxy-cinnamic acid and its ethyl ester in a drug substance and its formulation prototypes by HPLC-UV-DAD. J. Chromatogr. Sci. 2009, 47:315.
    • (2009) J. Chromatogr. Sci. , vol.47 , pp. 315
    • Soman, A.1    Jacob, S.2    Swanek, F.3
  • 23
    • 0032858854 scopus 로고    scopus 로고
    • Solid-phase extraction: method development, sorbents, and coupling with liquid chromatography
    • Hennion M.-C. Solid-phase extraction: method development, sorbents, and coupling with liquid chromatography. J. Chromatogr. A 1999, 856:3.
    • (1999) J. Chromatogr. A , vol.856 , pp. 3
    • Hennion, M.-C.1
  • 24
    • 0034648066 scopus 로고    scopus 로고
    • Recent developments in polymer-based sorbents for solid-phase extraction
    • Huck C.W., Bonn G.K. Recent developments in polymer-based sorbents for solid-phase extraction. J. Chromatogr. A 2000, 885:51.
    • (2000) J. Chromatogr. A , vol.885 , pp. 51
    • Huck, C.W.1    Bonn, G.K.2
  • 25
    • 84867097121 scopus 로고    scopus 로고
    • An overview of recent advances in HPLC instrumentation
    • Zotou A. An overview of recent advances in HPLC instrumentation. Cent. Eur. J. Chem. 2012, 10:554.
    • (2012) Cent. Eur. J. Chem. , vol.10 , pp. 554
    • Zotou, A.1
  • 26
    • 46149133770 scopus 로고
    • Improvement of selectivity and sensitivity by column switching in the determination of glycyrrhizin and glycyrrhetic acid in human plasma by high-performance liquid chromatography
    • De Groot G., Koops R., Hogendoorn E.A., Goewie C.E., Jean T., Savelkoul F., van Vloten P. Improvement of selectivity and sensitivity by column switching in the determination of glycyrrhizin and glycyrrhetic acid in human plasma by high-performance liquid chromatography. J. Chromatogr. A 1986, 456:71.
    • (1986) J. Chromatogr. A , vol.456 , pp. 71
    • De Groot, G.1    Koops, R.2    Hogendoorn, E.A.3    Goewie, C.E.4    Jean, T.5    Savelkoul, F.6    van Vloten, P.7
  • 27
    • 0029130893 scopus 로고
    • Two high-performance liquid chromatographic assays for the determination of free and total silibinin diastereomers in plasma using column switching with electrochemical detection and reversed-phase chromatography with ultraviolet detection
    • Rickling B., Hans B., Kramarczyk R., Krumbiegel G., Weyhenmeyer R. Two high-performance liquid chromatographic assays for the determination of free and total silibinin diastereomers in plasma using column switching with electrochemical detection and reversed-phase chromatography with ultraviolet detection. J. Chromatogr. B. Biomed. Sci. App. 1995, 670:267.
    • (1995) J. Chromatogr. B. Biomed. Sci. App. , vol.670 , pp. 267
    • Rickling, B.1    Hans, B.2    Kramarczyk, R.3    Krumbiegel, G.4    Weyhenmeyer, R.5
  • 28
    • 33846434851 scopus 로고    scopus 로고
    • Sensitive determination of aspirin and its metabolites in plasma by LC-UV using on-line solid-phase extraction with methylcellulose-immobilized anion-exchange restricted access media
    • Yamamoto E., Takakuwa S., Kato T., Asakawa N. Sensitive determination of aspirin and its metabolites in plasma by LC-UV using on-line solid-phase extraction with methylcellulose-immobilized anion-exchange restricted access media. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2007, 846:132.
    • (2007) J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. , vol.846 , pp. 132
    • Yamamoto, E.1    Takakuwa, S.2    Kato, T.3    Asakawa, N.4
  • 29
    • 84857047144 scopus 로고    scopus 로고
    • Selective comprehensive multi-dimensional separation for resolution enhancement in high performance liquid chromatography. Part I: principles and instrumentation
    • Groskreutz S.R., Swenson M.M., Secor L.B., Stoll D.R. Selective comprehensive multi-dimensional separation for resolution enhancement in high performance liquid chromatography. Part I: principles and instrumentation. J. Chromatogr. A 2012, 1228:31.
    • (2012) J. Chromatogr. A , vol.1228 , pp. 31
    • Groskreutz, S.R.1    Swenson, M.M.2    Secor, L.B.3    Stoll, D.R.4
  • 30
    • 78249231717 scopus 로고    scopus 로고
    • Targeted three-dimensional liquid chromatography: a versatile tool for quantitative trace analysis in complex matrices
    • Simpkins S.W., Bedard J.W., Groskreutz S.R., Swenson M.M., Liskutin T.E., Stoll D.R. Targeted three-dimensional liquid chromatography: a versatile tool for quantitative trace analysis in complex matrices. J. Chromatogr. A 2010, 1217:7648.
    • (2010) J. Chromatogr. A , vol.1217 , pp. 7648
    • Simpkins, S.W.1    Bedard, J.W.2    Groskreutz, S.R.3    Swenson, M.M.4    Liskutin, T.E.5    Stoll, D.R.6
  • 31
    • 64749096386 scopus 로고    scopus 로고
    • Comprehensive liquid chromatography: Fundamental aspects and practical considerations - a review
    • François I., Sandra K., Sandra P. Comprehensive liquid chromatography: Fundamental aspects and practical considerations - a review. Anal. Chim. Acta 2009, 641:14.
    • (2009) Anal. Chim. Acta , vol.641 , pp. 14
    • François, I.1    Sandra, K.2    Sandra, P.3
  • 34
    • 0034754966 scopus 로고    scopus 로고
    • Methylcellulose-immobilized reversed-phase precolumn for direct analysis of drugs in plasma by HPLC
    • Yamamoto E., Murata K., Ishihama Y., Asakawa N. Methylcellulose-immobilized reversed-phase precolumn for direct analysis of drugs in plasma by HPLC. Anal. Sci. 2001, 17:1155.
    • (2001) Anal. Sci. , vol.17 , pp. 1155
    • Yamamoto, E.1    Murata, K.2    Ishihama, Y.3    Asakawa, N.4
  • 35
    • 33745726212 scopus 로고    scopus 로고
    • Simplified gradient generator for micro- and nano-liquid chromatography
    • Murata K., Mano N., Asakawa N., Ishihama Y. Simplified gradient generator for micro- and nano-liquid chromatography. J. Chromatogr. A 2006, 1123:47.
    • (2006) J. Chromatogr. A , vol.1123 , pp. 47
    • Murata, K.1    Mano, N.2    Asakawa, N.3    Ishihama, Y.4
  • 36
    • 9944252509 scopus 로고    scopus 로고
    • Relevance of Frank's solvent classification as typically aqueous and typically non-aqueous to activities of firefly luciferase, alcohol dehydrogenase, and α-chymotrypsin in aqueous binaries
    • Fadnavis N.W., Seshadri R., Sheelu G., Madhuri K.V. Relevance of Frank's solvent classification as typically aqueous and typically non-aqueous to activities of firefly luciferase, alcohol dehydrogenase, and α-chymotrypsin in aqueous binaries. Arch. Biochem. Biophys. 2005, 433:454.
    • (2005) Arch. Biochem. Biophys. , vol.433 , pp. 454
    • Fadnavis, N.W.1    Seshadri, R.2    Sheelu, G.3    Madhuri, K.V.4
  • 37
    • 0642350827 scopus 로고
    • Hydrolysis of two acyl activated esters in water-rich 2-butoxyethanol-water mixtures. Effects of hydrophobic interactions on enthalpies, entropies, and heat capacities of activation
    • Holterman H.A.J., Engberts J.B.F.N. Hydrolysis of two acyl activated esters in water-rich 2-butoxyethanol-water mixtures. Effects of hydrophobic interactions on enthalpies, entropies, and heat capacities of activation. J. Am. Chem. Soc. 1980, 102:4256.
    • (1980) J. Am. Chem. Soc. , vol.102 , pp. 4256
    • Holterman, H.A.J.1    Engberts, J.B.F.N.2
  • 38
    • 67349153344 scopus 로고    scopus 로고
    • Effective on-line extraction of drugs from plasma using a restricted-access media column in column-switching HPLC equipped with a dilution system: application to the simultaneous determination of ER-118585 and its metabolites in canine plasma
    • Yamamoto E., Kato T., Mano N., Asakawa N. Effective on-line extraction of drugs from plasma using a restricted-access media column in column-switching HPLC equipped with a dilution system: application to the simultaneous determination of ER-118585 and its metabolites in canine plasma. J. Pharm. Biomed. Anal. 2009, 49:1250.
    • (2009) J. Pharm. Biomed. Anal. , vol.49 , pp. 1250
    • Yamamoto, E.1    Kato, T.2    Mano, N.3    Asakawa, N.4
  • 39
    • 0042579939 scopus 로고    scopus 로고
    • Autosampler carryover
    • Dolan J.W. Autosampler carryover. LC-GC Eur. 2001, 14:148.
    • (2001) LC-GC Eur. , vol.14 , pp. 148
    • Dolan, J.W.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.