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摘要
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 mu m 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 r(2) = 0.9997 in the concentration range of 5-100 mu g.mL(-1). The stress degradation was performed using acid, alkali, water, hydrogen peroxide and uv light.
- 出版日期2016-3
