Method development for the determination of cefdinir and its related substances by high-performance liquid chromatography.
The validation of the HPLC method used for the determination of cefdinir and its related substances is described. The developed method was specific and stability-indicating and provided a linear response with concentration. The system and method precision, expressed as relative standard deviations, were not greater than 1%, and the reproducibilities within and between laboratories were acceptable for the assay method. The procedure can quantitate related substances greater than approximately 0.05% of the principal cefdinir peak.
Okamoto
Y
Y
Fujisawa Pharmaceutical Co., Ltd., Osaka, Japan.
Itoh
K
K
Namiki
Y
Y
Matsushita
J
J
Fujioka
M
M
Yasuda
T
T
D002138:Calibration; D000077525:Cefdinir; D002511:Cephalosporins / Q000032:analysis* / Q000737:chemistry / Q000302:isolation & purification; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D011786:Quality Control; D015203:Reproducibility of Results; D012996:Solutions
D002511:Cephalosporins; D007202:Indicators and Reagents; D012996:Solutions; D000077525:Cefdinir