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  • Title: Development and validation of a HPLC-UV method for the determination in didanosine tablets.
    Author: de Oliveira AM, Löwen TC, Cabral LM, dos Santos EM, Rodrigues CR, Castro HC, dos Santos TC.
    Journal: J Pharm Biomed Anal; 2005 Jul 15; 38(4):751-6. PubMed ID: 15967304.
    Abstract:
    A simple, rapid, sensitive and specific reversed-phase high performance liquid chromatographic method involving ultraviolet detection (HPLC-UV) was developed for analysis of didanosine in drug substance and formulated products, tablets. Chromatography was carried out on a pre-packed, Lichrospher 100 Rp-8 (5.0 microm, 250 mm x 4.0 mm) column using 0.01 M sodium acetate solution:methanol (85:15, v/v) adjusted to pH 6.5 with acetic acid as mobile phase at a flow rate of 1.5 ml/min and a 248 nm detection. Hypoxantine was confirmed as the main degradation product. The assay was linear over the concentration range of 50-150 microg/ml (R approximately 0.999). The method was validated for accuracy and precision.
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