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