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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
W290017
Sigma-Aldrich
Phosphoric acid solution, 85 wt. % in H2O, FCC, FG
Pricing and availability is not currently available.
50812-U
Supelco
Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 7.5 cm × 2.1 mm
Pricing and availability is not currently available.
50816-U
Supelco
Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 5 cm × 3 mm
Pricing and availability is not currently available.
50511-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 7.5 cm × 2.1 mm
Pricing and availability is not currently available.
50521-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 25 cm × 2.1 mm
Pricing and availability is not currently available.
50523-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 5 cm × 3 mm
Pricing and availability is not currently available.
50541-U
Supelco
Ascentis® Express C18, 5 μm Guard Cartridge, 5 μm particle size, L × I.D. 5 mm × 3 mm, pkg of 3 ea
Pricing and availability is not currently available.
50525-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 7.5 cm × 3 mm
Pricing and availability is not currently available.
50507-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 2 cm × 2.1 mm
Pricing and availability is not currently available.
50508-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 3 cm × 2.1 mm
Pricing and availability is not currently available.
50527-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 15 cm × 3 mm
Pricing and availability is not currently available.
50542-U
Supelco
Ascentis® Express C18, 5 μm Guard Cartridge, 5 μm particle size, L × I.D. 5 mm × 4.6 mm, pkg of 3 ea
Pricing and availability is not currently available.
50518-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 15 cm × 2.1 mm
Pricing and availability is not currently available.
50522-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 3 cm × 3 mm
Pricing and availability is not currently available.
50528-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 25 cm × 3 mm
Pricing and availability is not currently available.
50517-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 10 cm × 2.1 mm
Pricing and availability is not currently available.
50529-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 3 cm × 4.6 mm
Pricing and availability is not currently available.
50526-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 10 cm × 3 mm
Pricing and availability is not currently available.
676780
Sigma-Aldrich
Methanol, ACS reagent, ≥99.8%
Pricing and availability is not currently available.
179337
Sigma-Aldrich
Methanol, ACS reagent, ≥99.8%
Pricing and availability is not currently available.
PHR1372
Supelco
Methanol, Pharmaceutical Secondary Standard; Certified Reference Material
Pricing and availability is not currently available.
50805-U
Supelco
Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 2 cm × 2.1 mm
Pricing and availability is not currently available.
50819-U
Supelco
Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 10 cm × 3 mm
Pricing and availability is not currently available.
50809-U
Supelco
Ascentis® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 3 cm × 2.1 mm
Pricing and availability is not currently available.
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
Pricing and availability is not currently available.
PHR1320
Supelco
Residual Solvent - Acetonitrile(solution in DMSO), Pharmaceutical Secondary Standard; Certified Reference Material
Pricing and availability is not currently available.
PHR1551
Supelco
Acetonitrile(Neat), Pharmaceutical Secondary Standard; Certified Reference Material
Pricing and availability is not currently available.
34860
Sigma-Aldrich
Methanol, suitable for HPLC, ≥99.9%
Pricing and availability is not currently available.
439193
Sigma-Aldrich
Methanol, suitable for HPLC, gradient grade, suitable as ACS-grade LC reagent, ≥99.9%
Pricing and availability is not currently available.
646377
Sigma-Aldrich
Methanol, HPLC Plus, ≥99.9%
Pricing and availability is not currently available.