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Quality by design approach for the separation of naproxcinod and its related substances by fused core particle technology column.

Journal of chromatographic science (2012-10-13)
Ugandar Reddy Inugala, Nageswara Rao Pothuraju, Ranga Reddy Vangala
ABSTRACT

This paper describes the development of a rapid, novel, stability-indicating gradient reversed-phase high-performance liquid chromatographic method and associated system suitability parameters for the analysis of naproxcinod in the presence of its related substances and degradents using a quality-by-design approach. All of the factors that affect the separation of naproxcinod and its impurities and their mutual interactions were investigated and robustness of the method was ensured. The method was developed using an Ascentis Express C8 150 × 4.6 mm, 2.7 µm column with a mobile phase containing a gradient mixture of two solvents. The eluted compounds were monitored at 230 nm, the run time was 20 min within which naproxcinod and its eight impurities were satisfactorily separated. Naproxcinod was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Naproxcinod was found to degrade significantly in acidic and basic conditions and to be stable in thermal, photolytic, oxidative and aqueous degradation conditions. The degradation products were satisfactorily resolved from the primary peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness.

MATERIALS
Product Number
Brand
Product Description

Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 7.5 cm × 2.1 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 3 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 10 cm × 4.6 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 7.5 cm × 3 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 10 cm × 2.1 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 3 cm × 3 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 2.1 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 3 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 4.6 mm
Supelco
Ascentis® Express C8, 2.7 μm Guard Cartridge, 2.7 μm particle size, L × I.D. 5 mm × 2.1 mm, pkg of 3 ea
Supelco
Ascentis® Express C8, 2.7 μm Guard Cartridge, 2.7 μm particle size, L × I.D. 5 mm × 3 mm, pkg of 3 ea
Supelco
Ascentis® Express C8, 2.7 μm Guard Cartridge, 2.7 μm particle size, L × I.D. 5 mm × 4.6 mm, pkg of 3 ea
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 3 cm × 4.6 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 10 cm × 3 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 7.5 cm × 4.6 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 3 cm × 2.1 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 4.6 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 2.1 mm
Supelco
Ascentis® Express C8, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 2 cm × 2.1 mm
Supelco
Ascentis® Express C8, 5 μm HPLC Column, 5 μm particle size, L × I.D. 10 cm × 3 mm
Supelco
Ascentis® Express C8, 5 μm HPLC Column, 5 μm particle size, L × I.D. 5 cm × 2.1 mm
Supelco
Ascentis® Express C8, 5 μm HPLC Column, 5 μm particle size, L × I.D. 25 cm × 3 mm
Supelco
Ascentis® Express C8, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 15 cm × 2.1 mm
Supelco
Ascentis® Express C8, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 3 cm × 3 mm
Supelco
Ascentis® Express C8, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 3 cm × 2.1 mm
Supelco
Ascentis® Express C8, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 7.5 cm × 2.1 mm
Supelco
Ascentis® Express C8, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 7.5 cm × 3 mm
Supelco
Ascentis® Express C8, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 10 cm × 3 mm
Supelco
Ascentis® Express C8, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 15 cm × 3 mm
Supelco
Ascentis® Express C8, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 5 cm × 2.1 mm