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Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles.
J Sep Sci. 2020 Jun 14 [Online ahead of print]JS

Abstract

In this paper, development of robust and reliable chaotropic chromatography method for the determination of aripiprazole and its impurities, following Analytical Quality by Design principles is presented. The efficient baseline separation and accurate determination of aripiprazole and its four impurities from tablets were set as Analytical Target Profile. In line with it, the influence of Critical Method Parameters (acetonitrile content, concentration of perchloric acid in water phase, and column temperature) on predefined Critical Method Attributes (separation of the critical pair of peaks, retention of the first and last eluting peak) was investigated with aid of the Central Composite Design. Further on Design Space, where Critical Method Parameters meet predefined acceptance limits with a high level of probability (π ≥ 85%), was computed as a result of performed Monte Carlo simulations. A normal operating conditions corresponding to 34% of acetonitrile, 66% of 42.5 mM perchloric acid, and column temperature at 35°C were selected from created Design Space. Robustness testing of the quantitative performances of the developed method was conducted combining Plackett-Burman design with alias matrix approach. Through the additional validation testing, reliability of the developed method for the use in the routine practice was completely confirmed.

Authors+Show Affiliations

Department of Drug Analysis, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.Department of Drug Analysis, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32535999

Citation

Rmandić, Milena, and Anħelija Malenović. "Chaotropic Chromatography Method Development for the Determination of Aripiprazole and Its Impurities Following Analytical Quality By Design Principles." Journal of Separation Science, 2020.
Rmandić M, Malenović A. Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles. J Sep Sci. 2020.
Rmandić, M., & Malenović, A. (2020). Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles. Journal of Separation Science. https://doi.org/10.1002/jssc.201900985
Rmandić M, Malenović A. Chaotropic Chromatography Method Development for the Determination of Aripiprazole and Its Impurities Following Analytical Quality By Design Principles. J Sep Sci. 2020 Jun 14; PubMed PMID: 32535999.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles. AU - Rmandić,Milena, AU - Malenović,Anħelija, Y1 - 2020/06/14/ PY - 2019/09/24/received PY - 2020/05/19/revised PY - 2020/06/09/accepted PY - 2020/6/15/pubmed PY - 2020/6/15/medline PY - 2020/6/15/entrez KW - alias matrix approach KW - analytical quality by design KW - aripiprazole impurities KW - chaotropic chromatography KW - robustness testing JF - Journal of separation science JO - J Sep Sci N2 - In this paper, development of robust and reliable chaotropic chromatography method for the determination of aripiprazole and its impurities, following Analytical Quality by Design principles is presented. The efficient baseline separation and accurate determination of aripiprazole and its four impurities from tablets were set as Analytical Target Profile. In line with it, the influence of Critical Method Parameters (acetonitrile content, concentration of perchloric acid in water phase, and column temperature) on predefined Critical Method Attributes (separation of the critical pair of peaks, retention of the first and last eluting peak) was investigated with aid of the Central Composite Design. Further on Design Space, where Critical Method Parameters meet predefined acceptance limits with a high level of probability (π ≥ 85%), was computed as a result of performed Monte Carlo simulations. A normal operating conditions corresponding to 34% of acetonitrile, 66% of 42.5 mM perchloric acid, and column temperature at 35°C were selected from created Design Space. Robustness testing of the quantitative performances of the developed method was conducted combining Plackett-Burman design with alias matrix approach. Through the additional validation testing, reliability of the developed method for the use in the routine practice was completely confirmed. SN - 1615-9314 UR - https://www.unboundmedicine.com/medline/citation/32535999/Chaotropic_chromatography_method_development_for_the_determination_of_aripiprazole_and_its_impurities_following_analytical_quality_by_design_principles L2 - https://doi.org/10.1002/jssc.201900985 DB - PRIME DP - Unbound Medicine ER -
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