Development and Validation for Concurrent Identification of Docetaxel and Fosamprenavir in Pharmaceutical Dosage Forms by using RP-HPLC

Abstract

This research work details the advancement & validation of an HPLC technique for the simultaneous estimation of Docetaxel & Fosamprenavir. Utilizing a Thermo Scientific Hypersil C18 column, the technique employs a MP of 50%  Na3PO4 buffer (pH 5) & 50% MeOH, with a flow of 1.0 mL per min and detection at 245 nanometer. System suitability tests showed a tailing factor below 2.0 and theoretical plates above 2000, confirming the method’s reliability. Validation parameters included assay, scale of linearity, precision, ID precision, accuracy, LOD, LOQ, & robustness. The assay demonstrated high precision with %RSD within acceptable limits. Linearity was confirmed over a concentration range of 20 to 100 ppm for both drugs, with a strong correlation coefficient. Accuracy was validated through recovery studies at 50%, 100%, and 150% concentrations, while robustness assessments confirmed the method’s reliability under variations in flow &MP ratio. This optimized HPLC technique is suitable for regular analysis of Docetaxel & Fosamprenavir, offering a reliable, efficient, and reproducible approach for pharmaceutical quality control.