title: Determination of biapenem in a medicinal product by micellar electrokinetic chromatography with sweeping in an enhanced electric field.
abstract: The elaborated method of micellar electrokinetic chromatography (MEKC) used to separate biapenem from its related substances was successfully implemented using sweeping under an enhanced electric field, followed by UV absorption detection at 200nm. The best results were obtained with formic buffer (22.5mM) pH 4.3 and sodium dodecyl sulfate (150mM) added to the electrolyte as the sweeping agent. Neutral capillary (60/50cm; 50μm ID) with reverse polarity and voltage values of 22kV, were used throughout the investigation. The optimized method of biapenem determination, validated in terms of linearity, accuracy and precision, provides a detection limit of 0.5μg/mL at S/N=3 for biapenem. The repeatability of the CE system, expressed by relative standard deviations (RSD) in the migration times, for biapenem and its degradation products varied from 0.14 to 1.48%, whereas for the corrected peak areas RSD were about 0.68-8.43%. Satisfactory separation was achieved within 20min of electrophoresis; moreover all carbapenems (imipenem, meropenem, ertapenem, doripenem and biapenem) were separated from each other during analysis. The evaluated MEKC method was applied to the analysis of a medicinal product containing biapenem - Omegacin(®) 0.3g for intravenous drip infusion.
authors: Department of Antibiotics and Microbiology, National Medicines Institute, Chełmska 30/34, 00-725 Warsaw, Poland. kmichalska@il.waw.pl
authors: Katarzyna
authors: K
authors: Michalska
authors: Judyta
authors: J
authors: Cielecka-Piontek
authors: Genowefa
authors: G
authors: Pajchel
authors: Stefan
authors: S
authors: Tyski
mesh_terms: D000890:Anti-Infective Agents / Q000032:analysis / Q000737:chemistry / Q000302:isolation & purification; D015780:Carbapenems / Q000302:isolation & purification; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D020374:Chromatography, Micellar Electrokinetic Capillary / Q000379:methods*; D004340:Drug Contamination; D057230:Limit of Detection; D016014:Linear Models; D019999:Pharmaceutical Solutions / Q000737:chemistry; D015203:Reproducibility of Results; D013845:Thienamycins / Q000032:analysis* / Q000737:chemistry / Q000302:isolation & purification
chemical_list: D000890:Anti-Infective Agents; D015780:Carbapenems; D019999:Pharmaceutical Solutions; D013845:Thienamycins; C065257:biapenem