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Volumn 55, Issue 2, 2011, Pages 247-252

Validation of an HPLC-UV method for the determination of ceftriaxone sodium residues on stainless steel surface of pharmaceutical manufacturing equipments

Author keywords

Ceftriaxone sodium; Cleaning validation; HPLC UV; Residues; Swab analysis

Indexed keywords

ACETONITRILE; CEFTRIAXONE; DRUG RESIDUE; STAINLESS STEEL; WATER;

EID: 79952241989     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.01.020     Document Type: Article
Times cited : (43)

References (23)
  • 1
    • 79952247022 scopus 로고    scopus 로고
    • Guide to Inspections Validation of Cleaning Processes, U.S. Food and Drug Administration, (FDA), Office of Regulatory Affairs, Washington, DC, (accessed 20.04.2009)
    • Guide to Inspections Validation of Cleaning Processes, U.S. Food and Drug Administration, (FDA), Office of Regulatory Affairs, Washington, DC, 1993, pp. 1-6, (accessed 20.04.2009). http://www.fda.gov//ora/inspect_ref/igs/valid.html.
    • , vol.1993 , pp. 1-6
  • 2
    • 0038064325 scopus 로고    scopus 로고
    • Development and validation of a liquid chromatographic method for the determination of the amlodipine residues on manufacturing equipment surfaces
    • Klinkenberg R., Streel B., Ceccato A. Development and validation of a liquid chromatographic method for the determination of the amlodipine residues on manufacturing equipment surfaces. J. Pharm. Biomed. Anal. 2003, 32:345-352.
    • (2003) J. Pharm. Biomed. Anal. , vol.32 , pp. 345-352
    • Klinkenberg, R.1    Streel, B.2    Ceccato, A.3
  • 3
    • 33847135774 scopus 로고    scopus 로고
    • Quantitative determination and sampling of azathioprine residues for cleaning validation in production area
    • Fazio T.T., Singh A.K., Kedor-Hackmann E.R.M., Santoro M.I.R.M. Quantitative determination and sampling of azathioprine residues for cleaning validation in production area. J. Pharm. Biomed. Anal. 2007, 43:1495-1498.
    • (2007) J. Pharm. Biomed. Anal. , vol.43 , pp. 1495-1498
    • Fazio, T.T.1    Singh, A.K.2    Kedor-Hackmann, E.R.M.3    Santoro, M.I.R.M.4
  • 4
    • 0033120887 scopus 로고    scopus 로고
    • Cleaning level acceptance criteria and a high pressure liquid chromatography procedure for the assay of Meclizine Hydrochloride residue in swabs collected from pharmaceutical manufacturing equipment surfaces
    • Mirza T., Lunn M.J., Keeley F.J., George R.C., Bodenmiller J.R. Cleaning level acceptance criteria and a high pressure liquid chromatography procedure for the assay of Meclizine Hydrochloride residue in swabs collected from pharmaceutical manufacturing equipment surfaces. J. Pharm. Biomed. Anal. 1999, 19:747-756.
    • (1999) J. Pharm. Biomed. Anal. , vol.19 , pp. 747-756
    • Mirza, T.1    Lunn, M.J.2    Keeley, F.J.3    George, R.C.4    Bodenmiller, J.R.5
  • 5
    • 79952251591 scopus 로고    scopus 로고
    • Merck & Co., Whitehouse Station, NJ, S. Budavari (Ed.)
    • The Merck Index 2001, 335. Merck & Co., Whitehouse Station, NJ. 13th ed. S. Budavari (Ed.).
    • (2001) The Merck Index , pp. 335
  • 7
    • 0022529264 scopus 로고
    • Determination of ceftriaxone by HPLC
    • Marini D., Balestrieri F. Determination of ceftriaxone by HPLC. Farmaco 1986, 41:172-176.
    • (1986) Farmaco , vol.41 , pp. 172-176
    • Marini, D.1    Balestrieri, F.2
  • 8
    • 0021638303 scopus 로고
    • Reversed-phase high-performance liquid chromatographic method to determine ceftriaxone in biological fluids
    • Bowman D.B., Aravind M.K., Miceli J.N., Kauffman R.E. Reversed-phase high-performance liquid chromatographic method to determine ceftriaxone in biological fluids. J. Chromatogr. 1984, 309:209-213.
    • (1984) J. Chromatogr. , vol.309 , pp. 209-213
    • Bowman, D.B.1    Aravind, M.K.2    Miceli, J.N.3    Kauffman, R.E.4
  • 10
    • 0024918113 scopus 로고
    • Ion-paired reversed phase high-performance liquid chromatography assay for determination of ceftriaxone in human plasma and urine
    • Jungbluth G.L., Jusko W.J. Ion-paired reversed phase high-performance liquid chromatography assay for determination of ceftriaxone in human plasma and urine. J. Pharm. Sci. 1989, 78:968-970.
    • (1989) J. Pharm. Sci. , vol.78 , pp. 968-970
    • Jungbluth, G.L.1    Jusko, W.J.2
  • 11
    • 0036605365 scopus 로고    scopus 로고
    • HPLC separation of antibiotics present in formulated and unformulated samples
    • Joshi S. HPLC separation of antibiotics present in formulated and unformulated samples. J. Pharm. Biomed. Anal. 2002, 28:795-809.
    • (2002) J. Pharm. Biomed. Anal. , vol.28 , pp. 795-809
    • Joshi, S.1
  • 12
    • 0033952278 scopus 로고    scopus 로고
    • A sensitive assay for the determination of cefazolin or ceftriaxone in plasma utilizing LC
    • Al-Rawithi S., Hussein R., Raines D.A., AlShowaier I., Kurdi W. A sensitive assay for the determination of cefazolin or ceftriaxone in plasma utilizing LC. J. Pharm. Biomed. Anal. 2000, 22:281-286.
    • (2000) J. Pharm. Biomed. Anal. , vol.22 , pp. 281-286
    • Al-Rawithi, S.1    Hussein, R.2    Raines, D.A.3    AlShowaier, I.4    Kurdi, W.5
  • 13
    • 0037142340 scopus 로고    scopus 로고
    • CE versus LC for simultaneous determination of amoxicillin/cluvalanic acid and ampicillin/sulbactam in pharmaceutical formulations for injections
    • Pajchel G., Owski K.P., Tyski S. CE versus LC for simultaneous determination of amoxicillin/cluvalanic acid and ampicillin/sulbactam in pharmaceutical formulations for injections. J. Pharm. Biomed. Anal. 2002, 29:75-81.
    • (2002) J. Pharm. Biomed. Anal. , vol.29 , pp. 75-81
    • Pajchel, G.1    Owski, K.P.2    Tyski, S.3
  • 14
    • 30744458606 scopus 로고    scopus 로고
    • Determination of ceftriaxone sodium in pharmaceutical formulations by flow injection analysis with acid potassium permanganate chemiluminiscence detection
    • Deyi Z., Yongjun M.A., Min Z., Li L.I., Hui C. Determination of ceftriaxone sodium in pharmaceutical formulations by flow injection analysis with acid potassium permanganate chemiluminiscence detection. Anal. Sci. 2006, 22:183-186.
    • (2006) Anal. Sci. , vol.22 , pp. 183-186
    • Deyi, Z.1    Yongjun, M.A.2    Min, Z.3    Li, L.I.4    Hui, C.5
  • 15
    • 0348110619 scopus 로고    scopus 로고
    • Development and validation of a liquid chromatographic method for determination of lacidipine residues on surfaces in the manufacture of pharmaceuticals
    • Nozal M.J., Bernal J.L., Jimenez J.J., Martin M.T., Diez F.J. Development and validation of a liquid chromatographic method for determination of lacidipine residues on surfaces in the manufacture of pharmaceuticals. J. Chromatogr. A 2004, 1024:115-122.
    • (2004) J. Chromatogr. A , vol.1024 , pp. 115-122
    • Nozal, M.J.1    Bernal, J.L.2    Jimenez, J.J.3    Martin, M.T.4    Diez, F.J.5
  • 16
    • 0037026372 scopus 로고    scopus 로고
    • Development and validation of an LC assay for sumatriptan succinate residues on surfaces in the manufacture of pharmaceuticals
    • Nozal M.J., Bernal J.L., Toribio L., Martin M.T., Diez F.J. Development and validation of an LC assay for sumatriptan succinate residues on surfaces in the manufacture of pharmaceuticals. J. Pharm. Biomed. Anal. 2002, 30:285-291.
    • (2002) J. Pharm. Biomed. Anal. , vol.30 , pp. 285-291
    • Nozal, M.J.1    Bernal, J.L.2    Toribio, L.3    Martin, M.T.4    Diez, F.J.5
  • 17
    • 0035369832 scopus 로고    scopus 로고
    • Validation of a liquid chromatographic method for the determination of ranitidine hydrochloride residues on surfaces in the manufacture of pharmaceuticals
    • Nozal M.J., Bernal J.L., Toribio L., Martin M.T., Diez F.J. Validation of a liquid chromatographic method for the determination of ranitidine hydrochloride residues on surfaces in the manufacture of pharmaceuticals. J. Chromatogr. A 2001, 919:87-93.
    • (2001) J. Chromatogr. A , vol.919 , pp. 87-93
    • Nozal, M.J.1    Bernal, J.L.2    Toribio, L.3    Martin, M.T.4    Diez, F.J.5
  • 18
    • 0034664090 scopus 로고    scopus 로고
    • Development and validation of an HPLC assay for fentanyl, alfentanil, and sufentanil in swab samples
    • Lambropoulos J., Spanos G.A., Lazaridis N.V. Development and validation of an HPLC assay for fentanyl, alfentanil, and sufentanil in swab samples. J. Pharm. Biomed. Anal. 2000, 23:421-428.
    • (2000) J. Pharm. Biomed. Anal. , vol.23 , pp. 421-428
    • Lambropoulos, J.1    Spanos, G.A.2    Lazaridis, N.V.3
  • 19
    • 33645998792 scopus 로고    scopus 로고
    • Determination of cefmetazole residue at pharmaceutical manufacturing facilities by chemiluminescence flow injection analysis
    • Fakutsu N., Konse T., Kawasaki T., Saito K., Nakazawa H. Determination of cefmetazole residue at pharmaceutical manufacturing facilities by chemiluminescence flow injection analysis. J. Pharm. Biomed. Anal. 2006, 41:599-602.
    • (2006) J. Pharm. Biomed. Anal. , vol.41 , pp. 599-602
    • Fakutsu, N.1    Konse, T.2    Kawasaki, T.3    Saito, K.4    Nakazawa, H.5
  • 20
    • 14644422155 scopus 로고    scopus 로고
    • A validated HPLC method for determining residues of a dual active ingredient anti-malarial drug on manufacturing equipment surfaces
    • Boca B., Apostolides Z., Pretorius E. A validated HPLC method for determining residues of a dual active ingredient anti-malarial drug on manufacturing equipment surfaces. J. Pharm. Biomed. Anal. 2005, 37:461-468.
    • (2005) J. Pharm. Biomed. Anal. , vol.37 , pp. 461-468
    • Boca, B.1    Apostolides, Z.2    Pretorius, E.3
  • 21
    • 79952242569 scopus 로고    scopus 로고
    • United States Pharmacopoeia, 32nd ed.
    • United States Pharmacopoeia, 32nd ed., 2010.
    • (2010)
  • 22
    • 79952252500 scopus 로고
    • ICH Harmonised Tripartite Guideline, Q2A, Text on Validation of Analytical Procedures, October 27
    • ICH Harmonised Tripartite Guideline, Q2A, Text on Validation of Analytical Procedures, October 27, 1994.
    • (1994)
  • 23
    • 79952251966 scopus 로고    scopus 로고
    • ICH Harmonised Tripartite Guideline, Impurities in New Drug Products, 3B(R2), Current Step 4 version, 2 June
    • ICH Harmonised Tripartite Guideline, Impurities in New Drug Products, 3B(R2), Current Step 4 version, 2 June 2006.
    • (2006)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.