Abstract：
:A limited number of studies with application of the Arrhenius equation have been reported to drugs and biopharmaceuticals in biological fluids at frozen temperatures. This paper describes stability studies of ampicillin and cephalexin in aqueous solution and human plasma applying the Arrhenius law for determination of adequate temperature and time of storage of these drugs using appropriate statistical analysis. Stability studies of the beta-lactams in human plasma were conducted at temperatures of 20°C, 2°C, -20°C and also during four cycles of freeze-thawing. Chromatographic separation was achieved using a Shimpak C(18) column, acetonitrile as organic modifier and detection at 215nm. LC-UV-MS/MS was used to demonstrate the conversion of ampicillin into two diastereomeric forms of ampicilloic acid. Stability studies demonstrated degradation greater than 10% for ampicillin in human plasma at 20°C, 2°C and -20°C after 15h, 2.7days, 11days and for cephalexin at the same temperatures after 14h, 3.4days and 19days, respectively, and after the fourth cycle of freezing-thawing. The Arrhenius plot showed good prediction for the ideal temperature and time of storage for ampicillin (52days) and cephalexin (151days) at a temperature of -40°C, but statistical analysis (least squares method) must be applied to avoid incorrect extrapolations and estimated values out uncertainty limits.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
do Nascimento TG,de Jesus Oliveira E,Basílio Júnior ID,de Araújo-Júnior JX,Macêdo ROdoi
10.1016/j.jpba.2012.04.010subject
Has Abstractpub_date
2013-01-25 00:00:00pages
59-64eissn
0731-7085issn
1873-264Xpii
S0731-7085(12)00207-5journal_volume
73pub_type
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