Column high-performance liquid chromatographic determination of norfloxacin and its main impurities in pharmaceuticals.
A gradient reversed-phase column high-performance liquid chromatographic method was developed for the detection and quantification of norfloxacin and its major impurities in norfloxacin-containing pharmaceuticals. Chromatographic separations were performed under the following experimental conditions: column, Zorbax SB RP-18 (5 microm, 250 x 4.6 mm); injection volume, 20 microL; mobile phase, 0.05 M NaH2PO4 (pH 2.5)-acetonitrile (87 + 13) for 16 min and (58 + 42) for 9 min (stepwise gradient); and flow rate, 1.3 mL/min. All analyses were performed at 25 degrees C, and the eluate was monitored at 275 nm using a diode array detector. Linearity (correlation coefficient = 0.999), recovery (99.3-101.8%), relative standard deviation (0.2-0.7%), and quantitation limit (0.12-0.47 microg/mL) were evaluated and found to be satisfactory. The method is simple, rapid, and convenient for purity control of norfloxacin in both raw materials and dosage forms.
Miseljić
Branislava
B
University of Belgrade, Faculty of Pharmacy, Department of Pharmaceutical Chemistry and Drug Analysis, Vojvode Stepe 450, P.O.B. 146, 11000 Belgrade, Serbia.
Popović
Gordana
G
Agbaba
Danica
D
Marković
Slavko
S
Simonovska
Breda
B
Vovk
Irena
I
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004340:Drug Contamination; D009643:Norfloxacin / Q000032:analysis*
D009643:Norfloxacin