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  • Development and validation of a novel stability-indicating HPLC method for the simultaneous assay of betamethasone-17-valerate, fusidic acid, potassium sorbate, methylparaben and propylparaben in a topical cream preparation.

Development and validation of a novel stability-indicating HPLC method for the simultaneous assay of betamethasone-17-valerate, fusidic acid, potassium sorbate, methylparaben and propylparaben in a topical cream preparation.

Journal of pharmaceutical and biomedical analysis (2014-04-16)
Jonathan Byrne, Trinidad Velasco-Torrijos, Robert Reinhardt
PMID24731970
ABSTRACT

A novel stability-indicating reversed phase high performance liquid chromatographic (RP-HPLC) method for the simultaneous assay of betamethasone-17-valerate, fusidic acid and potassium sorbate as well as methyl- and propylparaben in a topical cream preparation has been developed. A 100mm×3.0mm ID. Ascentis Express C18 column maintained at 30°C and UV detection at 240nm were used. A gradient programme was employed at a flow-rate of 0.75ml/min. Mobile phase A comprised of an 83:17 (v/v) mixture of acetonitrile and methanol and mobile phase B of a 10g/l solution of 85% phosphoric acid in purified water. The method has been validated according to current International Conference on Harmonisation (ICH) guidelines and applied during formulation development and stability studies. The procedure has been shown to be stability-indicating for the topical cream.

MATERIALS
Product Number
Brand
Product Description
717975
Sigma-Aldrich
Methanol, NMR reference standard
699608
Sigma-Aldrich
Phosphoric acid solution, NMR reference standard, 85% in D2O (99.9 atom % D), NMR tube size 3 mm × 8 in.
698822
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359769
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trans,trans-2,4-Hexadienoic acid potassium salt, ReagentPlus®, 99%
82762
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612162
Sigma-Aldrich
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322415
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34860
Sigma-Aldrich
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50819-U
Supelco
Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 10 cm × 3 mm
50805-U
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Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 2 cm × 2.1 mm
50809-U
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Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 3 cm × 2.1 mm
50811-U
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Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 5 cm × 2.1 mm
50821-U
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Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 15 cm × 3 mm
50822-U
Supelco
Ascentis® Express C18, 2 μm Guard Cartridge, 2 μm particle size, L × I.D. 5 mm × 2.1 mm, pkg of 3 ea
50813-U
Supelco
Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 10 cm × 2.1 mm
50812-U
Supelco
Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 7.5 cm × 2.1 mm
50814-U
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Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 15 cm × 2.1 mm
50816-U
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Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 5 cm × 3 mm
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50508-U
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50527-U
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50536-U
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50528-U
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50537-U
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Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 15 cm × 4.6 mm
50541-U
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Ascentis® Express C18, 5 μm Guard Cartridge, 5 μm particle size, L × I.D. 5 mm × 3 mm, pkg of 3 ea
50542-U
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Ascentis® Express C18, 5 μm Guard Cartridge, 5 μm particle size, L × I.D. 5 mm × 4.6 mm, pkg of 3 ea
50529-U
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Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 3 cm × 4.6 mm
50525-U
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Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 7.5 cm × 3 mm
50509-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 5 cm × 2.1 mm