Development and Validation of RP-HPLC Method for the Simultaneous Determination of Etoposide and Cisplatin and its Application in Quality Control of Injectable Dosage Forms

Etoposide and cisplatin are antineoplastic drugs used in injectable dosage forms in many kinds of cancer separately or in combination therapy. The objective of the work was to develop a simple and rapid RP-HPLC method for direct simultaneous determination of etoposide and cisplatin in injectable dosage forms, aiming its application in quality control analysis. The HPLC method was developed using C-18 ODS Hypersil column of 250 x 4.6 mm id with 5 mu m particle size, mobile phase of water : methanol : acetonitrile (40:35:25, v/v/v, pH 3.5) at a flow rate of 0.75 mL min(-1) and eluate detected at 283 nm. In the proposed methods, during simultaneous analysis cisplatin showed retention time of 3.12 min and etoposide 5.21 min within a continuous run of 10 min. The CV within-batch for low, medium and high concentrations of cisplatin were 0.94%, 0.16% and 0.14%, where as for etoposide these were 2.10%, 0.94% and 0.14% respectively. The CV between batches of cisplatin was 0.48%, 0.19% and 0.13% where as for etoposide 1.25%, 0.48% and 0.13%, respectively. The accuracy of the developed method was 98-99% with RSD of 0.2-0.3% which was within the limits of FDA guidelines.