DETERMINATION OF ZIDOVUDINE IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

摘要

A new reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and used for the estimation of didanosine (AZT) in bulk and pharmaceutical dosage forms using RPC-18 column using an isocratic HPLC system. The mobile phase consisted of acetonitrile and 0.05M potassium dihydrogen phosphate (pH 4.2) in the ratio of 50:50 at a flow rate of 1 mL/min. The run time was 15 min. Nelfinavir mesylate (NEM) (50μg/mL) was used as internal standard. The detection was carried out at 284 nm and the linearity was found to be in the range of 0.1-200 μg/mL. The retention times for drug (AZT) and internal standard (NEM) were 3.383 and 11.00 min respectively. Recovery studies shows that about 99.08% of AZT could be recovered from the preanalyzed samples indicating high accuracy of proposed method. There was no intra-day and inter-day variation found in the method of analysis. The mean drug content in branded DDI tablet dosage forms was quantified and found to be between 99.74 to 100.16%. The method was found to be simple, precise, specific, sensitive, and reproducible.