Development and validation of a stability-indicating LC-UV method for the determination of doripenem and biapenem in pharmaceutical dosage forms

• Autorzy: Cielecka-Piontek J. , Krause A , Zalewski P. , Lunzer A , Jelińska A.
• Języki publikacji: EN

Abstrakty

EN

A stability-indicating LC assay method was developed and validated for the quantitative determination of doripenem and biapenem in pharmaceutical dosage forms in the presence of degradation products formed during forced degradation studies. An isocratic RP-HPLC method was developed with a C-18 (250 mm × 4.6 mm, 5 μm) column and 12 mM ammonium acetate-acetonitrile (96:4 υ/υ) as mobile phase. The flow rate of the mobile phase was 1.0 mL min^-1 for doripenem and biapenem. The determination was carried out at the wavelength of 295 nm. The carbapenems were subjected to stress conditions of degradation in aqueous solutions including hydrolysis, oxidation, photolysis, and thermal degradation. The developed method was validated with respect to linearity, accuracy, precision, selectivity, and robustness.

Słowa kluczowe

EN

method validation; stability-indicating method; doripenem; biapenem

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2012
• Tom: Vol. 24, no. 2
• Strony: 207--219
• Opis fizyczny: Bibliogr. 23 poz., rys., tab.

Twórcy

autor

Cielecka-Piontek J.

• Poznan University of Medical Sciences Department of Pharmaceutical Chemistry, Faculty of Pharmacy Grunwaldzka 6 60-780 Poznań Poland

autor

Krause A

• PozLab Contract Research Organization Poznań Poland

autor

Zalewski P.

• Poznan University of Medical Sciences Department of Pharmaceutical Chemistry, Faculty of Pharmacy Grunwaldzka 6 60-780 Poznań Poland

autor

Lunzer A

• Tanaka Laboratory in Hokkaido University W 7, Kita-ku Sapporo 060-8638 Japan

autor

Jelińska A.

• Poznan University of Medical Sciences Department of Pharmaceutical Chemistry, Faculty of Pharmacy Grunwaldzka 6 60-780 Poznań Poland

Bibliografia

• [1] M. Hikida, M. Mori, and T. Kitta, Chemotherapy, 42, 101 (1994)
• [2] R.N. Jones, H.S. Sader, and T.H. Fritsche, Diagn. Microbiol. Infect. Dis., 52, 71 (2005)
• [3] H.M. Wexler, A.E. Engel, D. Glass, and C. Li, Antimicrob. Agents Chemother., 49, 4413 (2005)
• [4] C.M. Perry and T. Ibbotson, Drugs, 15, 2221 (2002)
• [5] F. Walsh, Ther. Clin. Risk Manag., 3, 789 (2007)
• [6] K. Ikawa, N. Morikawa, K. Ikeda, H. Ohge, and T. Sueda, Chemotherapy, 54, 386 (2008)
• [7] J. Patel and S.E. Cook, Am. J. Health Syst. Pharm., 54, 412 (1997)
• [8] R. Mendez, T. Alemany, and J.M. Villacorta, Chem. Pharm. Bull., 39, 831 (1991)
• [9] M. Zając, J. Cielecka-Piontek, and A. Jelińska, J. Pharm. Biomed. Anal., 43, 445 (2007)
• [10] J. Cielecka-Piontek, M. Zając, and A. Jelińska, J. Pharm. Biomed. Anal., 46, 52 (2008)
• [11] A. Mendez, J. Dalomo, M. Steppe, and E. Schapoval, J. Pharm. Biomed. Anal., 41, 1363 (2006)
• [12] Kayo, I. Kazuro, I. Aki, N. Yoshimi, M. Norifumi, J. Chromatogr. B, 844, 148 (2006)
• [13] Kayo, I. Kazuro, M. Norifumi, K. Keiko, U. Nami, O. Hiroki, and S. Taijiro, J. Chromatogr. B, 867, 20 (2008)
• [14] P.A. Psathas, K. Kuzmission, and S.Y. Ikeda, Clin. Ther., 30, 2075 (2008)
• [15] X. Ming, H. Tai-Jun, Z. Fei, L. Xiao-Min, and X. Xiang-Yang, J. Biomed. Pharm. Anal., 49, 937 (2009)
• [16] M. Bakshi, B. Singh, A. Singh, and S. Singh, J. Pharm. Biomed. Anal., 26, 891 (2001)
• [17] ICH, Stability Testing of New Drug Substances and Products (Q1AR). International Conference on Harmonization, IFPMA, Geneva, 2000
• [18] M. Bakshi, B. Singh, A. Singh, and S. Singh, J. Pharm. Biomed. Anal., 28, 1011 (2002)
• [19] R. Sehrawat, M. Maithani, R. Singh, Chromatographia, 72, 1 (2010)
• [20] J. Cielecka-Piontek, A. Lunzer, and A. Jelińska, Cent. Eur. J. Chem., 9, 35 (2011)
• [21] J. Cielecka-Piontek and A. Jelińska, React. Kinet. Mech. Cat., 102, 37 (2011)
• [22] J. Cielecka-Piontek and A. Jelińska, Spectrochim. Acta Mol. Biomol. Spectros., 77, 554 (2010)
• [23] J. Cielecka-Piontek, K. Michalska, P. Zalewski, A. Jelińska, Cur. Pharm. Anal., 7, 213 (2011)