Application of micellar electrokinetic chromatography to the determination of sultamicillin in oral pharmaceutical preparations.
A micellar electrokinetic capillary electrophoretic method for determination of sultamicillin in Unasyn oral preparations--tablets and suspension--was evaluated. Phosphate-borate buffer at pH 7.0 containing 1.0% sodium dodecylsulfate was used as a mobile phase. The elaborated method ensures separation of sultamicillin from p-toluenesulfonic acid and the impurities, ampicillin, sulbactam and penicillamine. The method was validated for specificity, reproducibility, precision, accuracy and assay linearity (in a concentration range of sultamicillin of 0.05-1.5 mg/ml). Statistical analysis by Student's t-test showed no significant differences between the results obtained by micellar electrokinetic chromatography and HPLC, t(calculated) 0.519 for suspension assays and 0.284 for tablets assays were smaller then t(tabulated).
Pajchel
Genowefa
G
Antibiotics and Microbiology Department, Drug Institute, 30/34 Chełmska St., 00-725 Warsaw, Poland. tyski@il.waw.pl
Tyski
Stefan
S
D000284:Administration, Oral; D000667:Ampicillin / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D020374:Chromatography, Micellar Electrokinetic Capillary / Q000379:methods*; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000737:chemistry*; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013407:Sulbactam / Q000032:analysis*
C035444:sultamicillin; D000667:Ampicillin; D013407:Sulbactam