Interlaboratory study of a supercritical fluid chromatography method for the determination of pharmaceutical impurities: Evaluation of multi-systems reproducibility

Amandine Dispas, Adrian Clarke, Alexandre Grand-Guillaume Perrenoud, Luca Gioacchino Losacco, Jean Luc Veuthey, Quentin Gros, Jérémy Molineau, Angéline Noireau, Caroline West, Fabio Salafia, Mariosimone Zoccali, Luigi Mondello, Amber Guillen, Jenny Wang, Kelly Zhang, Philipp Jochems, Gesa Schad, Kosuke Nakajima, Shinnosuke Horie, Jan JosephMaria Kristina Parr, Pierre Billemont, Antoni Severino, Sonja Schneider, Edgar Naegele, Daniel Kutscher, Rick Wikfors, Regina Black, Lee Ingvaldson, Jimmy Oliveira Da Silva, Raffeal Bennett, Erik L. Regalado, Thi Phuong Thuy Hoang, David Touboul, Yana Nikolova, Mariana Kamenova-Nacheva, Vladimir Dimitrov, Blair K. Berger, Kevin A. Schug, Solène Kerviel-Guillon, Fabien Mauge, Masatomo Takahashi, Yoshihiro Izumi, Takeshi Bamba, Florent Rouvière, Sabine Heinisch, Davy Guillarme, Philippe Hubert

研究成果: Contribution to journalArticle査読

2 被引用数 (Scopus)

抄録

Modern supercritical fluid chromatography (SFC) is now a well-established technique, especially in the field of pharmaceutical analysis. We recently demonstrated the transferability and the reproducibility of a SFC-UV method for pharmaceutical impurities by means of an inter-laboratory study. However, as this study involved only one brand of SFC instrumentation (Waters®), the present study extends the purpose to multi-instrumentation evaluation. Specifically, three instrument types, namely Agilent®, Shimadzu®, and Waters®, were included through 21 laboratories (n = 7 for each instrument). First, method transfer was performed to assess the separation quality and to set up the specific instrument parameters of Agilent® and Shimadzu® instruments. Second, the inter-laboratory study was performed following a protocol defined by the sending lab. Analytical results were examined regarding consistencies within- and between-laboratories criteria. Afterwards, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. Reproducibility variance was larger than that observed during the first study involving only one single type of instrumentation. Indeed, we clearly observed an ‘instrument type’ effect. Moreover, the reproducibility variance was larger when considering all instruments than each type separately which can be attributed to the variability induced by the instrument configuration. Nevertheless, repeatability and reproducibility variances were found to be similar than those described for LC methods; i.e. reproducibility as %RSD was around 15 %. These results highlighted the robustness and the power of modern analytical SFC technologies to deliver accurate results for pharmaceutical quality control analysis.

本文言語英語
論文番号114206
ジャーナルJournal of Pharmaceutical and Biomedical Analysis
203
DOI
出版ステータス出版済み - 9 5 2021

All Science Journal Classification (ASJC) codes

  • 分析化学
  • 薬科学
  • 創薬
  • 分光学
  • 臨床生化学

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