Development and validation of an HPLC-DAD method for the simultaneous identification and quantification of Topotecan, Irinotecan, Etoposide, Doxorubicin and Epirubicin

Abstract

The knowledge of the chemical stability of drugs prepared and administered in hospital is of paramount importance for establishing the methods and times of their preparation, as well as for ensuring patient safety. The objective of this work was to develop and validate a single chromatographic method, according to the International Conference on Harmonization (ICH), United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.) guidelines, to allow the determination of the chemical stability of 5 chemotherapy drugs. The high performance liquid chromatography coupled with diode array detection (HPLC-DAD) method developed was found to be linear (all analytical curves showed R2 ≥ 0.999), sensitive, precise (RSDs < 3%) and accurate (recovery values ​​ranging between 95% and 105%). The method was demonstrated to be robust to small deliberate variations such as column temperature, pH and composition of the mobile phase and also able to determine drug decomposition products. Therefore, the method described here is perfectly able to identify and quantify the chemotherapy drugs analysed.

Keywords

• HPLC-DAD
• Anticancer drugs
• Quality control