A NEW INVESTIGATIONAL METHOD FOR QUANTIFICATION AND VALIDATION OF ANALYTICAL METHOD FOR CEFIXIME AND ERDOSTEINE BY UPLC WITH PHOTO DIODE ARRAY DETECTOR IN BULK AND FORMULATION. APPLICATION TO THE ESTIMATION OF PRODUCT TRACES

摘要

Specific and innovative method was developed and validated for the identification and quantification of cefixime and erdosteine in the bulk and formulation samples by UPLC with PDA detector.The analytical technique was with buffer (pH: 7.0): methanol, (65:35%, V/V) using the Sunfire C_(18),5u,46mm×150mm analytical column with analysis time of six minutes. Flow of mobile phase through the column was 1.0 mL/min. Sample volume was 10 μL. Detection was carried at 254 nm in photo diode array detector. The retention times of cefixime and erdosteine were 2.012 min and 3.122 min., respectively. The curve indicates that correlation coefficient (r~2) was superior by having the value 1.000 with linear range of 20.0ng/ml_-200.0 ng/mL for Cefixime and 30 ng/mL-300.0 ng/mL for Erdosteine. The correlation coefficient (r~2) for erdosteine found 1.000. The LOQ for cefixime and erdosteine was 20ng/mL and 30ng/ml_ respectively. The LOD for cefixime and erdosteine was 1.0 ng/mL and 1.5ng/mL respectively. The developed method was applied for the bulk and formulation and equipement cleaning sample