DefinePK

Abstract

This study presents the development and validation of a reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Gemcitabine and Cisplatin in pharmaceutical formulations. The research addresses the growing need for reliable analytical techniques to monitor these widely used chemotherapeutic agents. Using a Thermosil C18 column (4.0 × 125 mm, 5 µm) and a mobile phase of Methanol and Sodium Acetate buffer (70:30% v/v) at pH 3.0, the method achieved efficient separation with detection at 252 nm. The flow rate was maintained at 0.7 mL/min, ensuring optimal peak resolution within a run time of 10 minutes. Validation parameters, including specificity, linearity, accuracy, precision, robustness, and limits of detection and quantification, were thoroughly evaluated per ICH guidelines. The findings indicate that this RP-HPLC method is reliable, reproducible, and suitable for routine quality control and pharmacokinetic studies.