Development and Validation of Rilpivirine in Pharmaceutical Formulation by RP-HPLC

Abstract

In the present study a simple isocratic reverse phase HPLC method was developed for the estimation of rilpivirine in pharmaceutical formulation. The separation was carried out using a column of Zorbax Eclipse XDB-C18, 250x4.6mmi.d with 5micron particle size. The mobile phase comprises of 0.03M di potassium hydrogen orthophosphate with pH adjusted to 2.5 using dilute ortho-phosphoric acid (mobile phase solvent-A) and acetonitrile (mobile phase solvent-B) in the ratio of 15: 85 (v/v).The flow rate was 1.0 ml/min and the effluents were monitored at 284 nm. The retention time was 7.19 min. The detector response was linear in the concentration range of 100300μg/ml. The respective linear regression equation being Y= 28817.742X-14741.2. The limit of detection (LOD) and limit of quantification (LOQ) for rilpivirine were found to be 0.05μg/ml and 0.15 μg/ml respectively. The assay was found to be 99.85%.The method was validated by determining its accuracy, precision and system suitability. 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 its pharmaceutical dosage form.