DEVELOPMENT AND VALIDATION OF A HPLC-UV METHOD FOR SIMULTANEOUS DETERMINATION OF CEFIXIME AND OFLOXACIN IN TABLET FORMULATIONAbstract
A simple, rapid, and sensitive high-performance liquid chromatographic method with UV detection has been developed and validated according to the ICH guidelines for the quantization of Cefixime (CFXM) and Ofloxacin (OFLO) in tablet preparation. Chromatographic separation was carried out in a Agilent Zorbax Eclipse XDB-C18 column (150 mm × 4.6 mm; 5 μm particle size) of Agilent Technologies with simple mobile phase composition of 25 mM KH2PO4 in water (pH 4.63, maintained by dil Phosphoric acid) and Methanol (65:35, v/v) at a flow rate of 0.5 ml min-1 with injection Volume of 20 µl where detector was set at 288 nm with a total run time of 10 mins. The method was linear over the concentration range of 20-100, μg ml-1 for both of CFXM and OFLO with a correlation coefficient of 0.999 and 0.999 respectively. Limit of quantifications (LOQ) of 5.53, 5.24 and limit of detections (LOD) 1.82, 1.73 μg ml-1 for CFXM and OFLO respectively. Accuracy and precision values of both within-run and between-run obtained from six different sets of three quality control (QC) samples analyzed in separate occasions for both the analytes ranged from 98.08% to 99.98% and 0.51% to 0.98%, respectively. Extraction recovery of analytes from 97.35% to 99.21%. The developed and validated method was successfully applied to quantitative determination of CFXM and OFLO in pharmaceutical formulation.
Sarbojit Kundu*, Tapas Majumder, Prasanta Kumar Barat and Subrata Kumar Ray
Central Drugs Laboratory, (Govt. of India), 3, Kyd Street, Kolkata-700 016, India.
16 September, 2014
13 January, 2014
30 January, 2014
01 February, 2015