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Volumn 55, Issue 2, 2011, Pages 379-384

Low level determinations of methyl methanesulfonate and ethyl methanesulfonate impurities in Lopinavir and Ritonavir Active pharmaceutical ingredients by LC/MS/MS using electrospray ionization

Author keywords

Ethyl methanesulfonates; LC MS MS; Lopinavir; Methyl methanesulfonates; Ritonavir

Indexed keywords

LOPINAVIR; MESYLIC ACID ETHYL ESTER; MESYLIC ACID METHYL ESTER; RITONAVIR;

EID: 79952244798     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.01.039     Document Type: Article
Times cited : (29)

References (15)
  • 1
    • 70350236480 scopus 로고    scopus 로고
    • Rdrug substanced and sensitive method for quantitative determination of Lopinavir and Ritonavir in human plasma by Liquid Chromatography-Tandem Mass Spectrometry
    • Temghare G.A., Shetye S.S., Joshi S.S. Rdrug substanced and sensitive method for quantitative determination of Lopinavir and Ritonavir in human plasma by Liquid Chromatography-Tandem Mass Spectrometry. J. Chem. 2009, 6:223-230.
    • (2009) J. Chem. , vol.6 , pp. 223-230
    • Temghare, G.A.1    Shetye, S.S.2    Joshi, S.S.3
  • 2
    • 33645866459 scopus 로고    scopus 로고
    • The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development
    • Dobo K.L., Greene N., Cyr M.O., Caron S., Ku W.W. The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development. Regul. Toxicol. Pharm. 2006, 44:282-293.
    • (2006) Regul. Toxicol. Pharm. , vol.44 , pp. 282-293
    • Dobo, K.L.1    Greene, N.2    Cyr, M.O.3    Caron, S.4    Ku, W.W.5
  • 3
    • 79952247261 scopus 로고
    • IARC, Monographs Program on the Evaluation of Carcinogenic Risks to Humans for methyl methanesulfonate 71 (1999) 1059; IARC Monographs Program on the Evaluation of Carcinogenic Risks to Humans for ethyl methanesulfonate
    • IARC, Monographs Program on the Evaluation of Carcinogenic Risks to Humans for methyl methanesulfonate 71 (1999) 1059; IARC Monographs Program on the Evaluation of Carcinogenic Risks to Humans for ethyl methanesulfonate 7 (1974) 245.
    • (1974) , vol.7 , pp. 245
  • 4
    • 79952246954 scopus 로고    scopus 로고
    • Guideline on the Limits of Genotoxic Impurities, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMEA), London, 28 June, (CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006)
    • Guideline on the Limits of Genotoxic Impurities, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMEA), London, 28 June, 2006 (CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006).
    • (2006)
  • 5
    • 79952251076 scopus 로고    scopus 로고
    • Genotoxic and carcinogenic impurities in drug substances and products: recommended approaches. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Silver Spring, MD, USA, December
    • Genotoxic and carcinogenic impurities in drug substances and products: recommended approaches. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Silver Spring, MD, USA, December 2008.
    • (2008)
  • 8
    • 9344245045 scopus 로고
    • Relative molar response of a flame ionization detector to some organic compounds containing sulfur
    • Filby W.G., Gunther K., Penzhorn R.D. Relative molar response of a flame ionization detector to some organic compounds containing sulfur. Anal. Chem. 1975, 47:2283-2285.
    • (1975) Anal. Chem. , vol.47 , pp. 2283-2285
    • Filby, W.G.1    Gunther, K.2    Penzhorn, R.D.3
  • 9
    • 3843114399 scopus 로고    scopus 로고
    • Trace analysis of residual methyl methanesulfonate, ethyl methanesulfonate and isopropyl methanesulfonate in pharmaceuticals by cdrug substancellary gas chromatography with flame ionization detection
    • Li W. Trace analysis of residual methyl methanesulfonate, ethyl methanesulfonate and isopropyl methanesulfonate in pharmaceuticals by cdrug substancellary gas chromatography with flame ionization detection. J. Chromatogr. A 2004, 1046:297-301.
    • (2004) J. Chromatogr. A , vol.1046 , pp. 297-301
    • Li, W.1
  • 10
    • 39149085994 scopus 로고    scopus 로고
    • Development and validation of GC-MS method for the determination of methyl methanesulfonate and ethyl methanesulfonate in imatinib mesylate
    • Ramakrishna K., Raman N.V.V.S.S., Narayana Rao K.M.V., Prasad A.V.S.S., Subhaschander Reddy K. Development and validation of GC-MS method for the determination of methyl methanesulfonate and ethyl methanesulfonate in imatinib mesylate. J. Pharm. Biomed. Anal. 2008, 46:780-783.
    • (2008) J. Pharm. Biomed. Anal. , vol.46 , pp. 780-783
    • Ramakrishna, K.1    Raman, N.V.V.S.S.2    Narayana Rao, K.M.V.3    Prasad, A.V.S.S.4    Subhaschander Reddy, K.5
  • 11
    • 23944465208 scopus 로고    scopus 로고
    • Determination of methyl and ethyl esters of methanesulfonic, benzenesulfonic and p-toluenesulfonic acids in active pharmaceutical ingredients by solid-phase microextraction (SPME) coupled to GC/SIM-MS
    • Colon I., Richoll S.M. Determination of methyl and ethyl esters of methanesulfonic, benzenesulfonic and p-toluenesulfonic acids in active pharmaceutical ingredients by solid-phase microextraction (SPME) coupled to GC/SIM-MS. J. Pharm. Biomed. Anal. 2005, 39:477-485.
    • (2005) J. Pharm. Biomed. Anal. , vol.39 , pp. 477-485
    • Colon, I.1    Richoll, S.M.2
  • 12
    • 0042346202 scopus 로고    scopus 로고
    • Determination of polar alkylating agents as thiocyanate/isothiocyanate derivatives by reaction headspace gas chromatography
    • Lee C.R., Guivarch F., Van Dau C.N., Tessier D., Krstulovic A.M. Determination of polar alkylating agents as thiocyanate/isothiocyanate derivatives by reaction headspace gas chromatography. Analyst 2003, 128:857-863.
    • (2003) Analyst , vol.128 , pp. 857-863
    • Lee, C.R.1    Guivarch, F.2    Van Dau, C.N.3    Tessier, D.4    Krstulovic, A.M.5
  • 13
    • 35349026723 scopus 로고    scopus 로고
    • A generic approach for the determination of residues of alkylating agents in active pharmaceutical ingredients by in situ derivatization-headspace-gas chromatography-mass spectrometry
    • Alzaga R., Ryan R.W., Taylor-Worth K., Lipczynski A.M., Szucs R., Sandra P. A generic approach for the determination of residues of alkylating agents in active pharmaceutical ingredients by in situ derivatization-headspace-gas chromatography-mass spectrometry. J. Pharm. Biomed. Anal. 2007, 45:472-479.
    • (2007) J. Pharm. Biomed. Anal. , vol.45 , pp. 472-479
    • Alzaga, R.1    Ryan, R.W.2    Taylor-Worth, K.3    Lipczynski, A.M.4    Szucs, R.5    Sandra, P.6
  • 14
    • 53049088565 scopus 로고    scopus 로고
    • A practical derivatization LC/MS approach for determination of trace level alkyl sulfonates and dialkyl sulfates genotoxic impurities in drug substances
    • An J., Sun M., Bai L., Chen T., Liu D.Q., Kord A. A practical derivatization LC/MS approach for determination of trace level alkyl sulfonates and dialkyl sulfates genotoxic impurities in drug substances. J. Pharm. Biomed. Anal. 2008, 48:1006-1010.
    • (2008) J. Pharm. Biomed. Anal. , vol.48 , pp. 1006-1010
    • An, J.1    Sun, M.2    Bai, L.3    Chen, T.4    Liu, D.Q.5    Kord, A.6
  • 15
    • 79952250834 scopus 로고    scopus 로고
    • ICH Q2B: Validation of analytical procedures: methodology, in: International Conference on Harmonization, Fed. Reg. (62 FR 27463), 19 May
    • ICH Q2B: Validation of analytical procedures: methodology, in: International Conference on Harmonization, Fed. Reg. (62 FR 27463), 19 May 1997.
    • (1997)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.