Method Development by HPLC for Estimation of Rilpivirine in Unit Bulk and Matrix Form

The main objective of the present work is to determine a novel, stability-indicating reversed phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative determination of Rilpivirine in active pharmaceutical ingredients and in its matrix by using a symmetry BDS Hypersil C8, 5µm, 15cmx4.6mm was used with a mobile phase containing a mixture of Methanol and water (containing 0.1 % OPA ) within the ratio of 80:20. The flow rate was 1.0 ml/min and effluent was monitored at 310 nm and a peak eluted at 5.50 min and column oven temperature was at room temperature. Calibration curve was plotted with a range from 5-25 µg/ml. The developed RP-HPLC method was validated according to the current International Conference on Harmonization (ICH) guidelines for specificity, LOD, LOQ, linearity, accuracy, precision, intermediate precision, assay and robustness. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Rilpivirine in bulk drug and in its matrix form.