Analytical Sciences

Development and Validation of a RP-HPLC Method for the Determination of Zidovudine and Its Related Substances in Sustained-release Tablets

Jucimary V. dos SANTOS,* Luís A. E. Batista de CARVALHO,** and M. Eugénia PINA*

*Centro de Estudos Farmacêuticos (CEF), Pharmaceutical Technology Laboratory, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal
**Unidade de I&D “Química-Física Molecular”, Chemistry Department, Faculty of Sciences and Technology, University of Coimbra, 3004-535 Coimbra, Portugal

A reversed-phase high-performance liquid chromatography (RP-HPLC) method for the rapid and accurate quantification of zidovudine (AZT) in sustained release tablets during stability testing was developed. A Waters RP-18 XTerra™^® column, using a water:methanol (80:20, v/v%) mobile phase at a flow rate of 1.0 ml min⁻¹, and UV detection at 266 nm, was employed. The method of validation parameters indicate a linear range of between 40.0 to 220.0 μg ml⁻¹ with an LOQ of 1.985 μg ml⁻¹ and an LOD of 0.655 μg ml⁻¹ for the analyte. The degradation products of AZT were isolated and characterized for the first time. There was a very little decline of antiviral by heat, and AZT did not completely degrade either by acid or alkaline hydrolysis. On the other hand, oxidation caused a higher degradation stress in the drug. Finally, the degradation products resulting from stress studies were not found to interfere with the detection of antiviral, which is an advantage of the presently proposed method.

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