title: Development and Validation of HPLC and HPTLC Methods for Determination of Cefoperazone and Its Related Impurities.
abstract: Validated sensitive and highly selective methods were developed for the quantitative determination of cefoperazone sodium (CEF) in the presence of its reported impurities; 7-aminocephalosporanic acid (7-ACA) and 5-mercapto-1-methyl-tetrazole (5-MER). Method A is high-performance liquid chromatography (HPLC), where the mixture of CEF and the reported impurities; 7-ACA and 5-MER were separated on a C8 column (5 µm ps, 250 mm × 4.6 i.d.) using methanol:0.05 M KH2PO4 buffer (22.5:77.5 v/v, pH 7.5) as a mobile phase. The three components were detected at 254 nm with a concentration range of 10-90 µg mL(-1) and the mean percentage recovery 99.67% (SD 1.465). Method B is high-performance thin layer chromatography (HPTLC), where the mixture of CEF and the reported impurities were separated on silica gel HPTLC F254 plates using (acetone:methanol:ethyl acetate:2% sodium lauryl sulfate:glacial acetic acid) (3:2:3:0.8:0.2, by volume) as a developing system and scanning at 254 nm over a concentration range of 1-10 µg per band with the mean percentage recovery 99.95% (SD 1.335). The proposed methods were statistically compared with a reported HPLC method with no significant difference regarding accuracy and precision; indicating the ability of the proposed methods to be reliable and suitable for routine analysis of drug product. The proposed HPTLC method proved to be more sensitive, while the HPLC gave more reproducible results besides saving time.
authors: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef 62514, Egypt.
authors: Eglal A
authors: EA
authors: Abdelaleem
authors: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef 62514, Egypt Pharmaceutical Chemistry Department, Faculty of Pharmacy, University of Tabuk, Tabuk 71491, Kingdom of Saudi Arabia.
authors: Ibrahim A
authors: IA
authors: Naguib
authors: Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini, Cairo 11562, Egypt.
authors: Hala E
authors: HE
authors: Zaazaa
authors: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef 62514, Egypt essraa_88@yahoo.com.
authors: Essraa A
authors: EA
authors: Hussein
mesh_terms: D002438:Cefoperazone / Q000032:analysis*; D002511:Cephalosporins / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002855:Chromatography, Thin Layer / Q000379:methods*; D004340:Drug Contamination
chemical_list: D002511:Cephalosporins; D002438:Cefoperazone; C030735:7-aminocephalosporanic acid