RP-HPLC method development & validation of rilpivirine pharmaceutical dosage form
Keywords:RP-HPLC, Rilpivirine, Method development and validation, ICH Guidelines.
A simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been developed for the determination of Rilpivirine in bulk and pharmaceutical dosage form dosage form. The chromatographic method was standardized using Develosil ODS HG-5 RP C18, 5µm, 15cm x 4.6mm i.d. column with UV detection at 205 nm and 0.1% Ortho phosphoric acid and Acetonitrile with 65:35 ratio at a flow rate of 1.0 ml/ min. The proposed method was successfully applied to the determination of Rilpivirine in bulk and pharmaceutical dosage form. The method was linear over the range of 20-70µg/ml. The recovery was in the range of 98% to 102% and limit of detection was found to be 0.8 µg/ml and quantification was found to be 2.4 µg/ml. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization (ICH) guidelines.