Developing of an analytic method and forced degradation study of emtricitabine and tenofovir alafenamide using RP-HPLC techniques

A reverse phase high performance liquid chromatographic (RP-HPLC) method is presented for the quantification of Emtricitabine (EMT) and Tenofovir Alafenamide (TEN) in combination. Separation was achieved under optimized chromatographic condition on an Inertsil C18, 250 x 4.6 mm, 5μm column. Various composition of mobile phase was tried. Separation of EMT and TEN was started with HPLC grade Acetonitrile: Water, Methanol: Water and Methanol: Buffer and Methanol finally using solvent system of Buffer (pH 3.5) and Methanol in ratio of (30:70) and flow rate adjust at 1.0 ml/min was used as solvent system, The detection was carried out at 262nm nm using Shimazdu UV-visible detector SPD20AT. The mobile phase run time for the developed analytical method was 10 minutes. The standard curve was found linear in the concentration range of 20-60 μg/ ml (r2- 0.9994) and 2.5-7.5 μg/ ml (r2-0.9992) for EMT and TEN respectively. forced degradation study of the EMT and TEN was also carried out at various conditions. The proposed developed RP-HPLC method was validated statistically and the values were found to be within the acceptable limits. In conclusion, the developed RP-HPLC method was found to be simple, specific, and rugged for simultaneous estimation of EMT and TEN. Validation results of method was found within the acceptable limits. Hence it can be used for analysis of EMT and TEN.

Author(s): Khushboo M. Patel

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