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Volumn 78, Issue 2, 2010, Pages 215-231

Evaluation of the pharmaceutical quality of docetaxel injection using new stability indicating chromatographic methods for assay and impurities

Author keywords

Docetere; Excipients; HPLC; Impurities; Quality; Stability indicating

Indexed keywords

DOCETAXEL; PACLITAXEL; POLYSORBATE 80;

EID: 77954644210     PISSN: 00368709     EISSN: 22180532     Source Type: Journal    
DOI: 10.3797/scipharm.0912-14     Document Type: Article
Times cited : (15)

References (13)
  • 1
    • 84864917888 scopus 로고    scopus 로고
    • Taxotere Summary of product Characteristics
    • Taxotere Summary of product Characteristics: http://www.emea.europa.eu/humandocs/PDFs/EPAR/taxotere/H-073-PI-en.pdf
  • 2
    • 84864929039 scopus 로고    scopus 로고
    • Taxotere Label information
    • Taxotere Label information http://www.fda.gov/cder/foi/label/2007/020449s045lbl.pdf
  • 3
    • 32444440249 scopus 로고    scopus 로고
    • Ramachandra P,Sekhar NM, Reddy DNM, Srinivasa NR Isolation and characterization of impurities in docetaxel
    • doi:10.1016/j.jpba.2005.10.037
    • Vasu DR, Moses Babu J, Vyas K, Sai RP, Ramachandra P,Sekhar NM, Reddy DNM, Srinivasa NR Isolation and characterization of impurities in docetaxel. J Pharm Biomed Anal. 2006; 40: 614-622. doi:10.1016/j.jpba.2005.10.037
    • (2006) J Pharm Biomed Anal , vol.40 , pp. 614-622
    • Vasu, D.R.1    Moses, B.J.2    Vyas, K.3    Sai, R.P.4
  • 4
    • 33847333703 scopus 로고    scopus 로고
    • Isolation and characterization of degradation impurities in docetaxel drug substance and its formulation
    • doi:10.1016/j.jpba.2006.10.015
    • Kumar D, Tomar RS, Deolia SK, Mitra M, Mukherjee R, Burman AC. Isolation and characterization of degradation impurities in docetaxel drug substance and its formulation. J Pharm Biomed Anal. 2007; 43: 1228-1235. doi:10.1016/j.jpba.2006.10.015
    • (2007) J Pharm Biomed Anal , vol.43 , pp. 1228-1235
    • Kumar, D.1    Tomar, R.S.2    Deolia, S.K.3    Mitra, M.4    Mukherjee, R.5    Burman, A.C.6
  • 7
    • 0035882748 scopus 로고    scopus 로고
    • Rapid high-performance liquid chromatographic determination of docetaxel (Taxotere) in plasma using liquid-liquid extraction
    • doi:10.1016/S0378-4347(01)00238-9
    • Ciccolini J, Catalin J, Blachon MF, Durand A. Rapid high-performance liquid chromatographic determination of docetaxel (Taxotere) in plasma using liquid-liquid extraction. J Chromatogr B Biomed Sci Appl. 2001; 759: 299-306. doi:10.1016/S0378-4347(01)00238-9
    • (2001) J Chromatogr B Biomed Sci Appl , vol.759 , pp. 299-306
    • Ciccolini, J.1    Catalin, J.2    Blachon, M.F.3    Durand, A.4
  • 8
    • 0031011837 scopus 로고    scopus 로고
    • Sensitive determination of docetaxel in human plasma by liquid-liquid extraction and reversed-phase high-performance liquid chromatography
    • doi:10.1016/S0378-4347(97)00089-3
    • Loos WJ, Verweij J, Nooter K, Stoter G, Sparreboom A. Sensitive determination of docetaxel in human plasma by liquid-liquid extraction and reversed-phase high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl. 1997; 693: 437-441. doi:10.1016/S0378-4347(97)00089-3
    • (1997) J Chromatogr B Biomed Sci Appl , vol.693 , pp. 437-441
    • Loos, W.J.1    Verweij, J.2    Nooter, K.3    Stoter, G.4    Sparreboom, A.5
  • 9
    • 0032582253 scopus 로고    scopus 로고
    • A rapid reversed phase high performance liquid chromatographic method for the determination of docetaxel (Taxotere®) in human plasma using a column switching technique
    • doi:10.1016/S0731-7085(97)00233-1
    • Rouini MR, Lotfolahi A, Stewart DJ, Molepo JM, Shirazi FH, Vergniol JC, Tomiak E, Delorme F, Vernillet L, Giguere M, Goel R. A rapid reversed phase high performance liquid chromatographic method for the determination of docetaxel (Taxotere®) in human plasma using a column switching technique. J Pharm Biomed Anal. 1998; 17: 1243-1247. doi:10.1016/S0731-7085(97)00233-1
    • (1998) J Pharm Biomed Anal , vol.17 , pp. 1243-1247
    • Rouini, M.R.1    Lotfolahi, A.2    Stewart, D.J.3    Molepo, J.M.4    Shirazi, F.H.5    Vergniol, J.C.6    Tomiak, E.7    Delorme, F.8    Vernillet, L.9    Giguere, M.10    Goel, R.11
  • 10
    • 77954650082 scopus 로고    scopus 로고
    • HPLC for determination of docetaxel by injection
    • Long Yu J, Li Yan Q, Yi J. HPLC for determination of docetaxel by injection: Zhongguo Yiyao Gongye Zazhi. 2006; 37: 708-709.
    • (2006) Zhongguo Yiyao Gongye Zazhi , vol.37 , pp. 708-709
    • Long, Y.J.1    Li, Y.Q.2    Yi, J.3
  • 12
    • 47949128986 scopus 로고    scopus 로고
    • Pharmaceutical quality of docetaxel generics versus originator drug product: A comparative analysis
    • doi:10.1185/03007990802207874
    • Vial J, Cohen M, Sassiat P, Thiébaut D. Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis: Curr Med Res Opin. 2008; 24: 2019-2033. doi:10.1185/03007990802207874
    • (2008) Curr Med Res Opin , vol.24 , pp. 2019-2033
    • Vial, J.1    Cohen, M.2    Sassiat, P.3    Thiébaut, D.4
  • 13
    • 77954653865 scopus 로고    scopus 로고
    • Stability Testing of New Drug Substances and Products (Q1AR2), ICH Harmonised: Tripartite Guideline
    • Stability Testing of New Drug Substances and Products (Q1AR2), ICH Harmonised: Tripartite Guideline.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.