Stability-indicating methods for quantitative determination of zidovudine and stavudine in capsules

Abstract

Recebido em 2/3/05; aceito em 5/8/05; publicado na web em 20/1/06 Zidovudine (AZT) and stavudine (D4T) are nucleoside reverse transcriptase inhibitors extensively used in human immunodeficiency virus (HIV) infected patients. In order to evaluate the quality of these drugs, two stability indicating HPLC methods were developed. The validated methods were applied in quantitative determination of AZT, D4T and their induced degradation products in capsule preparations. The stability studies were conducted at controlled temperature and relative humidity conditions based on the International Conference on Harmonization stability studies protocol for Zone IV areas. Easy sample preparation and low-cost make these methods especially useful for quality control and stability studies of AZT and D4T in drug products.

Molecularly imprinted polymer for analysis of zidovudine and stavudine in human serum by liquid chromatography–mass spectrometry

“…Zidovudine and stavudine are the most widely used NRTIs in AIDS treatment [3]. Analytical methods, including either high performance liquid chromatography (HPLC) [1][2][3][4][5][6][7][8][9] or capillary electrophoresis (CE) [1,10] have been used to quantify zidovudine (AZT) or stavudine (d4T) in biological media. Most of these methods used solid-phase extraction (SPE) as preliminary treatment.…”

Post-dispensing stability surveillance: Stavudine

“…Stavudine may degrade to thymine under hydrolytic, oxidative and photolytic conditions 4 . Furthermore other research has shown that stavudine capsules stored at 50°C/90% RH, presented more than a ten fold increase in thymine, the degradation product of stavudine during the 90 day study period 8 .…”

“…Stavudine is one of the most widely used substances in the treatment of the acquired immunodeficiency syndrome 8 . The South African National Antiretroviral Treatment Guidelines include stavudine in its first line treatment regimen 2 .…”

Voltammetric Determination of Azidothymidine Using Silver Solid Amalgam Electrodes

“…Several analytical methods have been developed for the determination of AZT alone or simultaneously with other NRTI [4,5], in plasma [6,7], other biological fluids [8], or pharmaceutical preparations [9 -14]. Methods based on liquid chromatography prevail, either coupled with ultra violet (UV) detection [5,8,10,11,14] or more recently coupled with tandem mass spectrometry (MS/MS) [6,7]. Several immunoassays have been also described (e.g., radioimmunoassay [15] and amperometric immunoassays [12,13]).…”