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Development and Validation of RP-HPLC Method for the Determination of Tenofovir Disoproxil in Bulk and in Pharmaceutical Formulation

Zaheer Ahmed, Sathish Kumar Shetty, B. Gopinath, Manzoor Ahmed and B. K. Sridhar

Tenofovir disoproxil (TD) is a prodrug of tenofovir. It is a novel antiviral drug, which is highly efficient in the treatment of human hepatitis B virus (HBV) and HIV. A simple, selective, linear, accurate and precise RP-HPLC method was developed and validated for routine analysis of tenofovir disoproxil in bulk and in pharmaceutical formulation. Isocratic elution at a flow rate of 1.0 mL/min was employed on a Thermo Hypersil HyPURITY C18 reversed-phase column (150 mm × 2.1 mm i.d., 5 µm) at ambient temperature. The mobile phase consisted of acetonitrile and 0.05 mM phosphate buffer pH 6.0 (50 : 50, v/v). The UV detection wavelength was 260 nm and 20 µL of sample was injected. The retention time for tenofovir disoproxil is 4.45 min. Determining sensitivity, accuracy, precision, robustness, stability, specificity, selectivity, and system suitability parameters validated the proposed method.