Development and validation of the stability-indicating LC-UV method for the determination of cefoselis sulphate

• Authors: Przemysław Zalewski , Judyta Cielecka-Piontek , Anna Jelińska
• Languages of publication: EN

Abstracts

EN

The stability-indicating LC assay method was developed and validated for quantitative determination of cefoselis sulphate in the presence of degradation products formed during the forced degradation studies. An isocratic, RP-HPLC method was developed with C-18 (250 × 4.6 mm, 5 µm) column and 12 mM ammonium acetate-acetonitrile (95:5 V/V) as a mobile phase. The flow rate of the mobile phase was 1.0 mL min−1. Detection wavelength was 260 nm and temperature was 30°C. Cefoselis similarly to other cephalosporins was subjected to stress conditions of degradation in aqueous solutions including hydrolysis, oxidation, photolysis and thermal degradation. The developed method was validated with regard to linearity, accuracy, precision, selectivity and robustness. The method was applied successfully for identification and determination of cefoselis sulphate in pharmaceuticals and during kinetic studies.

Keywords

EN

Method validation; Stability-indicating method; Cefoselis sulphate

• Publisher: De Gruyter Open
• Journal: Open Chemistry
• Year: 2012
• Volume: 10
• Issue: 1
• Pages: 121-126

Dates

published

1 - 2 - 2012

online

24 - 11 - 2011

Contributors

author

Przemysław Zalewski

• Poznan University of Medical Sciences

author

Judyta Cielecka-Piontek

• Poznan University of Medical Sciences

author

Anna Jelińska

• Poznan University of Medical Sciences

References

• [1] T. Kuriyama, T. Karasawa, K. Nakagawa, S. Nakamura, E. Yamamoto, Oral Microbiol. Immunol. 17, 285 (2002) http://dx.doi.org/10.1034/j.1399-302X.2002.170504.x[Crossref]
• [2] M.W. Climo, S.M. Markowitz, D.S. Williams, C.G. Hale-Cooper, G.L. Archer, J. Antimicrob. Chemother. 40, 59 (1997) http://dx.doi.org/10.1093/jac/40.1.59[Crossref]
• [3] H.C. Neu, N.X. Chin, H.B. Huang, Antimicrob Agents Chemother 37(3), 566 (1993) [Crossref]
• [4] G. Patel, S. Rajput, Acta Chromatogr. 23(2), 215 (2011) http://dx.doi.org/10.1556/AChrom.23.2011.2.3[Crossref]
• [5] Y. Ikeda, J. Ban, T. Ishikawa, S. Hashiguchi, S. Urayama, H. Horibe, Chem. Pharm. Bull. 56(10), 1406 (2008) http://dx.doi.org/10.1248/cpb.56.1406[Crossref]
• [6] A. Jelińska, L. Dobrowolski, I. Oszczapowicz, J. Pharm. Biomed. Anal. 35(5), 1273 (2004) http://dx.doi.org/10.1016/j.jpba.2004.03.017[Crossref]
• [7] T. Sugioka, T. Asano, Y. Chikaraishi, E. Suzuki, A. Sano, T. Kuriki, M. Shirotsuka, K. Saito, Chem. Pharm. Bull. 38(7), 1998 (1990) http://dx.doi.org/10.1248/cpb.38.1998[Crossref]
• [8] J.O. Fubara, R.E. Notari, J. Pharm. Sci. 87(12), 1572 (1998) http://dx.doi.org/10.1021/js980170y[Crossref]
• [9] B. Medenecka, A. Jelińska, M. Zając, M. Bałdyka, K. Juszkiewicz, I. Oszczapowicz, Acta Pol. Pharm. 66(5), 563 (2009) [PubMed]
• [10] A. Jelińska, B. Medenecka, M. Zając, M. Knajsiak, Acta Pol. Pharm. 65(2), 261 (2008) [PubMed]
• [11] M. Zając, A. Jelińska, P. Zalewski, Acta Pol. Pharm. 62(2), 89 (2005) [PubMed]
• [12] A. Jelińska, I. Dudzińska, M. Zając, I. Oszczapowicz, W. Krzewski Acta Pol. Pharm. 62(3)183 (2005) [PubMed]
• [13] M. Zając, A. Jelińska, L. Dobrowolski, I. Oszczapowicz, J. Pharm. Biomed. Anal. 32(6), 1181 (2003) http://dx.doi.org/10.1016/S0731-7085(03)00237-1[Crossref]
• [14] A. Jelińska, M. Zając, J. Gostomska, M. Szczepaniak, Farmaco 58(4), 309 (2003) http://dx.doi.org/10.1016/S0014-827X(02)00023-X[Crossref]
• [15] A. Jelińska, M. Zając, M. Jakubowska, React. Kinet. Catal. Lett. 73(2), 325 (2001) http://dx.doi.org/10.1023/A:1014175710690[Crossref]
• [16] J. Cielecka-Piontek, K. Michalska, P. Zalewski, A. Jelińska, Curr. Pharm. Anal. 7(4), 213 (2011)
• [17] K. Ohtaki, K. Matsubara, S. Fujimaru, K. Shimizu, T. Awaya, M. Suno, K. Chiba, N. Hayase, H. Shiono, J. Neural. Transm. 111, 1523 (2004) http://dx.doi.org/10.1007/s00702-004-0177-0[Crossref]
• [18] H. Ueo, H. Motohashi, T. Katsura, K. Inui, Biochemical Pharmacology 70, 1104 (2005) http://dx.doi.org/10.1016/j.bcp.2005.06.024[Crossref]
• [19] M. Nagata, M. Yasuhara, Biol. Pharm. Bull. 24(9), 1049 (2001) http://dx.doi.org/10.1248/bpb.24.1049[Crossref]
• [20] ICH Q2B, Validation of Analytical Procedures, Methodology, International Conference on Harmonization (IFPMA, Geneva, 2000)
• [21] M. Bakshi, B. Singh, A. Singh, S. Singh, J. Pharm. Biomed. Anal. 26, 891 (2001) http://dx.doi.org/10.1016/S0731-7085(01)00475-7[Crossref]
• [22] M. Bakhi, S. Singh, J. Pharm. Biomed. Anal. 28, 1011 (2002) http://dx.doi.org/10.1016/S0731-7085(02)00047-X[Crossref]
• [23] R. Sehrawat, M. Maithani, R. Singh, Chromatographia 72, 1 (2010) http://dx.doi.org/10.1365/s10337-010-1612-z[Crossref]

Identifiers

DOI

10.2478/s11532-011-0112-9