Development and validation of a new and economical stability indicating RP-HPLC method for cefixime trihydrate

• Main Authors: Ceema Mathew, Bellamkonda Swathi, Makula Ajitha, Puvvadi Sathesh Babu
• Format: Article
• Language: English
• Published: Universidade de São Paulo
• Series: Brazilian Journal of Pharmaceutical Sciences
• Subjects: High Performance Liquid Chromatography/quantitative analysis; Degradation; Stability-indicating; Cefixime trihydrate/determination.
• Online Access: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000100010&lng=en&tlng=en

ABSTRACT The present work describes the development of a new high performance liquid chromatographic (HPLC) method for the determination of Cefixime trihydrate under different stress conditons as specified by ICH. For the analysis, a Phenomenex (250 x 4.6 mm, 5 µm particle size) ODS column and a SPD 20 A UV detector at 289 nm was used. The selected mobile phase was 10 mM disodium hydrogen phosphate (with 0.5% TEA, pH adjusted to 6.3 with OPA) and methanol in the ratio of 75:25 (v/v) in isocratic mode at a flow rate of 1 mL.min-1.The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9997 in the concentration range of 5-100 μg.mL-1. The stress degradation was performed using acid, alkali, water, hydrogen peroxide and uv light.