TY - JOUR
T1 - Development and validation of an HPLC-DAD method for the simultaneous identification and quantification of Topotecan, Irinotecan, Etoposide, Doxorubicin and Epirubicin
AU - Sanogo, Seydou
AU - Silimbani, Paolo
AU - Gaggeri, Raffaella
AU - Masini, Carla
N1 - Funding Information:
The authors would like to thank Cristiano Verna and Grainne Eileen Tierney for the article editing service.
Publisher Copyright:
© 2020 The Authors
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
KW - Anticancer drugs
KW - HPLC-DAD
KW - Quality control
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U2 - 10.1016/j.arabjc.2020.11.002
DO - 10.1016/j.arabjc.2020.11.002
M3 - Article
AN - SCOPUS:85096535392
VL - 14
JO - Arabian Journal of Chemistry
JF - Arabian Journal of Chemistry
SN - 1878-5352
IS - 1
M1 - 102896
ER -