Development and validation of a new and economical stability indicating RP-HPLC method for cefixime trihydrate
Autor: | Ceema Mathew, Bellamkonda Swathi, Makula Ajitha, Puvvadi Sathesh Babu |
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Jazyk: | angličtina |
Předmět: | |
Zdroj: | Brazilian Journal of Pharmaceutical Sciences, Vol 52, Iss 1, Pp 87-94 |
Druh dokumentu: | article |
ISSN: | 2175-9790 1984-8250 |
DOI: | 10.1590/S1984-82502016000100010 |
Popis: | 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. |
Databáze: | Directory of Open Access Journals |
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