RP-HPLC Method Validation for the Assay of Tenofovir Disoproxil Orotate

Abstract

A new Isocractic RP-HPLC method was established for the assay of Tenofovir disoproxil orotate. As per ICH guidelines, the method was validated by using a chromatographic column YMC Pack ODS-AQ, (250mm x4.6mm x 5μm particle size,) at a temperature of 300C and an Isocractic mobile phase of 0.1% Triethylamine buffer, adjusted the pH to 6.0 with ortho phosphoric and acetonitrile in the ratio of (55%: 45%) was used with a flow rate of 1.0mLmin-1. The diluent is a mixture of water and acetonitrile in the ratio of (95:5v/v) and the sample cooler temperature was 5°C. The injection volume was 10μL and detection was achieved at 260nm with UV and PDA detector system for UV detection. The % RSD, Linearity, Range, Accuracy, Precision, Ruggedness (Intermediate Precision) and Robustness are found to be satisfactory. Therefore the method is assumed to be suitable for the assay of the Tenofovir disoproxil orotate by RP-HPLC method.