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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
53799-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 2 cm × 2.1 mm, pk of 1 ea
53823-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 10 cm × 2.1 mm, pk of 1 ea
53826-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 5 cm × 4.6 mm, pk of 1 ea
53827-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 10 cm × 4.6 mm, pk of 1 ea
53825-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 15 cm × 2.1 mm, pk of 1 ea
53829-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 15 cm × 4.6 mm, pk of 1 ea
53819-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 7.5 cm × 4.6 mm, pk of 1 ea
53822-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 5 cm × 2.1 mm, pk of 1 ea
582711-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 5 cm × 1 mm, pk of 1 ea
609781
Sigma-Aldrich
Phosphoric acid-16O4 solution, 70 wt. % in D2O, 99.9 atom % 16O
53998-U
Supelco
Ascentis® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 500 μm
54271-U
Supelco
Ascentis® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 300 μm
53992-U
Supelco
Ascentis® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 300 μm
53814-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 10 cm × 3 mm, pk of
53816-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 15 cm × 3 mm, pk of 1 ea
53812-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 7.5 cm × 3 mm, pk of
54273-U
Supelco
Ascentis® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 500 μm
53818-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 3 cm × 4.6 mm, pk of 1 ea
53508-U
Supelco
Ascentis® Express C18, 2.7 Micron Guard Cartridge, 2.7 μm particle size, L × I.D. 5 mm × 4.6 mm, pkg of 3 ea
53793-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 15 cm × 10 mm, pk of 1 ea
53501-U
Supelco
Ascentis® Express C18, 2.7 Micron Guard Cartridge, 2.7 μm particle size, L × I.D. 5 mm × 2.1 mm, pkg of 3 ea
53504-U
Supelco
Ascentis® Express C18, 2.7 Micron Guard Cartridge, 2.7 μm particle size, L × I.D. 5 mm × 3 mm, pkg of 3 ea
45983
Supelco
Acetonitrile, analytical standard
53802-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 3 cm × 2.1 mm, pk of 1 ea
53804-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 7.5 cm × 2.1 mm, pk of 1 ea
53805-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 3 cm × 3 mm, pk of 1 ea
452289
Sigma-Aldrich
Phosphoric acid, ≥85 wt. % in H2O, ≥99.999% trace metals basis
271004
Sigma-Aldrich
Acetonitrile, anhydrous, 99.8%
53811-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 5 cm × 3 mm, pk of 1 ea
345245
Sigma-Aldrich
Phosphoric acid, 85 wt. % in H2O, 99.99% trace metals basis