Method Development and Validation for the Determination of Four Potential Impurities Present in Darunavir Tablets by Reverse Phase-Ultra-Performance Liquid Chromatography Coupled with Diode-Array Detector

摘要

The present paper describes strategic development and validation of stability-indicating method for the determination of impurities present in Darunavir tablets. Separation of impurities at satisfactory level is achieved in 100mm lengthx2.1mm ID, octadecyl column with 1.8 mu m particle size. Mobile phase buffer consists of 0.1% orthophosphoric acid in water adjusted the pH 3.0 with triethylamine and acetonitrile using gradient elution mode. Finalized flow rate was 0.2mL min(-1) with a monitoring wavelength of 265nm. Developed method was successfully validated for specificity, linearity, precision, accuracy, determination of limit of detection, limit of quantification, and robustness as per International Conference on Harmonization general guidelines requirement. The proposed validated reverse phase-ultra-performance liquid chromatography (RP-UPLC) method was shorter in run time and successfully used for quantification of all process and degradation impurities present in Darunavir tablets.