A NEW STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CEFIXIME AND LINEZOLID IN PHARMACEUTICAL DOSAGE FORM AND PLASMA SAMPLE

Satyanarayana Battu*, Vasudev Pottbathini

A new stability indicating HPLC method was developed and validated for the determination of Cefixime and Linezolid in tablet dosage form and spiked plasma sample. The chromatographic separation was achieved on a XTerra RP-18 (150mm x 4.6mm, 5µm) stationary phase maintained at a temperature of 30 ºC with a mobile phase combination of 1% Orthophosphoric acid and Methanol (60:40) at a flow rate of 1.0 mL min-1 and the detection was carried out by using UV detector at 250 nm. The total run time was 8 minutes. The retention time of Cefixime and Linezolid were found to be 3.815 min and 5.665 min respectively. Further forced degradation study of Cefixime and Linezolid has been carried out in various stress conditions. Both compounds were found to be sensitive to all accelerated conditions like acid, base, light, heat and oxidation. The performance of the method was validated according to the present ICH guidelines. Cefixime is found to be linear in the range of 100-300 µg mL-1 and Linezolid is found to be linear in the range of 300-900 µg mL-1 . The limit of detection and limit of quantification was found to be 0.6 µg mL-1 and 2.46 µg mL-1 for Cefixime and 2.01 µg mL-1 and 8.21 µg mL-1 for Linezolid. The proposed method was found to be simple, sensitive, accurate and can be applied for qualitative, quantitative and stability studies.