Simultaneous determination of ampicillin, cefoperazone, and sulbactam in pharmaceutical formulations by HPLC with beta-cyclodextrin stationary phase.
An accurate and reproducible method for the simultaneous determination of ampicillin (AMP), sulbactam (SUL), and cefoperazone (CFP) in pharmaceutical formulations by using HPLC with beta-CD stationary phase was developed. It involved the use of the added tetraethylammonium acetate (TEAA) reagent, pH, and methanol as the significant parameters to find the optimum separation condition. A high resolution and selectivity of analytes was obtained by running the mobile phase in methanol-5 mM TEAA buffer = 35:65 (v/v, pH 4.5) at 280 nm. The mean recoveries ranged from 96.6 to 103.3% for AMP in the synthetic mixture, 97.6 to 103.0% for SUL, and 97.0 to 104.0% for CFP. The low LOD (<1.8 microg/mL) and low CV (<0.9%) assured that this method was sensitive and reproducible. The assay of analytes in commercial products exhibited that it was convenient and reproducible for routine analyses of these components in sterilized H(2)O, saline, or 5% dextrose injection solutions.
Tsou
Tai-Li
TL
Graduate Institute of Pharmaceutical Sciences, College of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan, ROC.
Huang
Yu-Chuan
YC
Lee
Chiu-Wey
CW
Lee
An-Rong
AR
Wang
Hsian-Jenn
HJ
Chen
Su-Hwei
SH
D000667:Ampicillin / Q000032:analysis*; D002438:Cefoperazone / Q000032:analysis*; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002845:Chromatography / Q000379:methods; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004338:Drug Combinations; D005947:Glucose / Q000032:analysis; D000432:Methanol / Q000737:chemistry; D008956:Models, Chemical; D015203:Reproducibility of Results; D013407:Sulbactam / Q000032:analysis*; D013696:Temperature; D047392:beta-Cyclodextrins / Q000032:analysis*
D004338:Drug Combinations; D047392:beta-Cyclodextrins; C035444:sultamicillin; D000667:Ampicillin; D002438:Cefoperazone; C057923:sulperazone; D005947:Glucose; C031215:betadex; D013407:Sulbactam; D000432:Methanol