An ultra-high-performance chromatography method to study the long term stability of gemcitabine in dose banding conditions - Université de Lille Accéder directement au contenu
Article Dans Une Revue Journal of Pharmaceutical and Biomedical Analysis Année : 2023

An ultra-high-performance chromatography method to study the long term stability of gemcitabine in dose banding conditions

Résumé

Gemcitabine is an analogue of cytidine arabinoside, used alone or in combination chemotherapy to treat various type of cancer. The dose-banding of gemcitabine provides the opportunity to anticipate the preparation of this anticancer drug on condition of carrying out stability studies. The aim of this study is to develop and validate a stability-indicating ultra-high-performance Liquid Chromatography (UHPLC) method for measuring the concentration of gemcitabine and to evaluate its stability at standardised rounded doses in polyolefin bags. The UHPLC with photodiode array (PDA) detector method was developed and validated (linearity, precision, accuracy, limits of detection and quantification, robustness and degradation test). Thirty polyolefin bags of gemcitabine (1600 mg/292 ml (n = 10), 1800 mg/297 ml (n = 10) and 2000 mg/303 ml (n = 10)) were prepared under aseptic conditions and stored at 5 ± 3 °C and 23 ± 2 °C for 49 days. Physical stability tests were periodically performed: visual and microscopic inspection and optical densities. The chemical stability was evaluated through pH monitoring and chromatographic assays. The results confirm the stability of Gemcitabine at selected standardised rounded doses of 1600 mg, 1800 mg and 2000 mg in NaCl 0.9% polyolefin bags for at least 49 days at 5 ± 3 °C and 23 ± 2 °C, allowing in-advance preparation.
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Dates et versions

hal-04226121 , version 1 (03-10-2023)

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Melanie Closset, Marie-Lise Colsoul, Nicolas Goderniaux, Benoît Bihin, Jacques Jamart, et al.. An ultra-high-performance chromatography method to study the long term stability of gemcitabine in dose banding conditions. Journal of Pharmaceutical and Biomedical Analysis, 2023, Journal of Pharmaceutical and Biomedical Analysis, 227, pp.115290. ⟨10.1016/j.jpba.2023.115290⟩. ⟨hal-04226121⟩

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