Abstract
A simple, rapid, and stability-indicating RP-HPLC method for a combination of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and efavirenz (EFV) was developed and validated with the help of a suitable statistical software as an application tool for the quality by design. The drugs individually, and in combination, were subjected to forced degradation (thermal, photolytic, hydrolytic, and oxidative stress conditions) and accelerated stability studies (40 ± 1°C/75 ± 3% RH for three months). Successful separation of combined drugs from degradation products was achieved by gradient elution on a reverse-phase C18 column, using a mobile phase containing phosphate buffer (pH 3.5): acetonitrile at 1.5 mL min−1 flow rate, detection wavelength 256 nm, column oven temperature 25°C, and injection volume 10 μL. Linearity was established in the range of 20–300 μg mL−1, 24.5–367.5 μg mL−1 and 60–900 μg mL−1 for FTC, TDF, and EFV, respectively. The method was successfully applied for quantifying the drugs in marketed dosage forms and on stability samples.
Highlights
Around 33.4 million people were living with HIV in year 2008 and around 2 million people have died in the same year [1]
A simple, rapid, and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for a combination of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and efavirenz (EFV) was developed and validated with the help of a suitable statistical so ware as an application tool for the quality by design. e drugs individually, and in combination, were subjected to forced degradation and accelerated stability studies (40 ± 1∘C/75 ± 3% RH for three months)
TDF, a nucleotide reverse-transcriptase inhibitor (NRTI) blocks the enzyme reverse transcriptase, an essential enzyme that is required for the replication of viral
Summary
Around 33.4 million people were living with HIV in year 2008 and around 2 million people have died in the same year [1]. A xed dose combination of tenofovir, emtricitabine, and efavirenz, was approved by the Food and Drug Administration (FDA) on July 12, 2006, for the treatment of this disease. Several HPLC methods are available in the literature for individual drugs and for a combination with other drugs for determination of TDF, FTC, and EFV, but no stability-indicting assay method (SIAM) has been reported [6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21]. The present study was planned to develop stability-indicating assay RP-HPLC method for the simultaneous determination of TDF, FTC, and EFV in presence of interaction/degradation product. Designed experiments were performed by varying different method parameters such as buffer concentration, pH of mobile phase, ow rate, mobile phase composition, and column temperature, to study the effect of these method parameters on system suitability criteria of all three drugs as a part of the robustness study
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