Development and validation of a new stability indicating reversed phase liquid chromatographic method for the determination of prednisolone acetate and impurities in an ophthalmic suspension

Marley, Adrian and Stalcup, Apryll M. and Connolly, Damian (2015) Development and validation of a new stability indicating reversed phase liquid chromatographic method for the determination of prednisolone acetate and impurities in an ophthalmic suspension. Journal of Pharmaceutical and Biomedical Analysis, 102. pp. 261-266. ISSN 0731-7085

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Abstract

A new stability indicating reversed phase high performance liquid chromatography (RP-HPLC) method was developed and validated under current International Conference of Harmonisation (ICH) guidance for the determination of prednisolone acetate (PAC) and impurities in an ophthalmic suspension. The developed method is presented as an alternative to a modified version of the current RP-HPLC method described in the USP monograph for the assay of PAC in an ophthalmic suspension. Along with the assay of PAC, the new method is also capable of identifying and quantifying eight selected PAC impurities and degradation products in an ophthalmic suspension. Using an Agilent Poroshell 120 EC-C18 100mm×4.6mm (dp: 2.7μm) column set to 60°C with step gradient elution generated using mobile phase A: acetonitrile/water (10:90) (v/v) and mobile phase B: acetonitrile delivered at 1.2mLmin-1, all peaks of interest are eluted in 33min with resolution of 1.5 between the critical pairs. The developed method was validated for PAC and impurities to ICH recommendations for accuracy, linearity, precision (repeatability), limit of detection, limit of quantitation, robustness and specificity.

Item Type:	Article
Additional Information:	Funding Information: The authors wish to thank the management of Allergan Pharmaceuticals Ireland Ltd. for supporting this work. The authors also acknowledge Science Foundation Ireland for funding under the Strategic Research Cluster Programme (Grant Number 08/SRC/B1412 ). Publisher Copyright: © 2014 Elsevier B.V.
Uncontrolled Keywords:	/dk/atira/pure/subjectarea/asjc/1600/1602
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Depositing User:	Admin SSL
Date Deposited:	19 Oct 2022 23:03
Last Modified:	07 Jun 2023 18:42
URI:	http://repository-testing.wit.ie/id/eprint/3789

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