Analytical Method Development and Validation for Simultaneous Estimation of Epirubicin and Docetaxel in Bulk and Pharmaceutical Dosage form by Using RP-HPLC

Abstract

A simple, rapid, and reliable Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Epirubicin and Docetaxel in bulk and pharmaceutical dosage forms. The chromatographic separation was achieved using a Phenomenex Luna C18 column (4.6 x 150 mm, 5 μm) at an optimized temperature of 35ºC. The mobile phase consisted of methanol and water in a 70:30 v/v ratio, with a flow rate of 1 ml/min, and detection was performed at 230 nm. The injection volume was 10 μL, and the total run time was 10 minutes. The method was validated as per standard guidelines, demonstrating excellent linearity, precision, accuracy, and sensitivity for both drugs. The results confirmed that the method was specific, reproducible, and suitable for the quality control analysis of Epirubicin and Docetaxel in bulk and dosage forms. This RP-HPLC method offers a fast and efficient approach for the simultaneous determination of these drugs, making it an ideal tool for routine analysis in pharmaceutical industries.