STABILITY-INDICATING HPLC ASSAY OF ZIDOVUDINE IN EXTEMPORANEOUS SYRUP

This investigation was undertaken to develop a stability-indicating hi gh performance liquid chromatographic (HPLC) assay for zidovudine (AZT ) in an extemporaneous oral liquid form. A gradient elution HPLC assay was developed to quantitate AZT, dissolved as 100 mg/10 mL in syrup U SPXXII, stored in amber glass vials at 50 and 25 degrees C for 2 and 1 7 weeks, respectively. The degradation of AZT in syrup reserved in col orless glass vials was also tested for 2.5 weeks. Six replicate sample s were analyzed for each time period at each temperature. Although 17% of AZT stored in colorless glass vials degraded after 2.5 weeks, only 5% degraded after 2 weeks of keeping AZT at 50 degrees C in amber gla ss vials.