Development and validation of a HPLC-UV method for the determination in didanosine tablets.
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.
de Oliveira
Antonia Maria Cavalcanti
AM
Instituto Vital Brazil, Niteroi, RJ 24310-110, Brazil. ferrcaval@ig.com.br
Löwen
Teresa Cristina Raposo
TC
Cabral
Lúcio Mendes
LM
dos Santos
Elizabeth Moreira
EM
Rodrigues
Carlos Rangel
CR
Castro
Helena C
HC
dos Santos
Tereza Cristina
TC
D019380:Anti-HIV Agents / Q000032:analysis*; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D016049:Didanosine / Q000032:analysis*; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D010084:Oxidation-Reduction; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D019380:Anti-HIV Agents; D007202:Indicators and Reagents; D013607:Tablets; D016049:Didanosine