Chromatographic Separation and in Vitro Dissolution Assessment of Tenofovir disoproxil fumarate, Emtricitabine and Nevirapine in a Fixed Dose Combination of Antiretrovirals.
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Date
2014-11
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Abstract
A rapid, economic and robust stability indicating HPLC method was developed and validated to quantify
Tenofovir disoproxil Fumarate (TDF), Emtricitabine (EMT) and Nevirapine (NVP) simultaneously at single
wavelength (254 nm) in order to assess the in vitro drug release profile from tablet formulations.
Chromatographic separation was performed with a gradient elution of samples on a 4.6 mm x 150 mm, 5 μm,
Inertsil ODS-2 column with buffered mobile phase containing solvent A (10 Mm ammonium acetate buffer, pH
4.6) and solvent B ( acetonitrile) at a flow rate of 1.0 mL/min). In dissolution studies, the sink condition was
optimized based on quantitative solubility of TDF, EMT and NVP standards in different dissolution medium as
recommended by USP. The proposed HPLC method and dissolution test condition were validated as per ICH
guidelines. The results obtained meet the regulatory criteria thereby confirming that the method is suitable for
routine quality control analysis and in vitro dissolution studies.
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Keywords
HPLC, Validation, Dissolution studies, Dissolution studies, Tenofovir disoproxil Fumarate, Emtricitabine, Nevirapine
Citation
Jayapalu Kalpana, Malipeddi Himaja, Chinnasamy Anbarasu. Chromatographic Separation and in Vitro Dissolution Assessment of Tenofovir disoproxil fumarate, Emtricitabine and Nevirapine in a Fixed Dose Combination of Antiretrovirals. Journal of Applied Pharmaceutical Science. 2014 Nov; 4(11): 76-80.