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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
P5811
Sigma-Aldrich
Phosphoric acid, BioReagent, suitable for insect cell culture, 85%
79617
Sigma-Aldrich
Phosphoric acid, BioUltra, ≥85% (T)
85520
Sigma-Aldrich
Potassium sorbate, purum p.a., ≥99.0% (NT)
45983
Supelco
Acetonitrile, analytical standard
271004
Sigma-Aldrich
Acetonitrile, anhydrous, 99.8%
53802-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 3 cm × 2.1 mm
452289
Sigma-Aldrich
Phosphoric acid, ≥85 wt. % in H2O, ≥99.999% trace metals basis
53805-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 3 cm × 3 mm
53811-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 3 mm
53816-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 3 mm
54273-U
Supelco
Ascentis® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 500 μm
53814-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 10 cm × 3 mm
53812-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 7.5 cm × 3 mm
53799-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 2 cm × 2.1 mm
606723
Sigma-Aldrich
Methanol-12C, 99.95 atom % 12C
53823-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 10 cm × 2.1 mm
609781
Sigma-Aldrich
Phosphoric acid-16O4 solution, 70 wt. % in D2O, 99.9 atom % 16O
53825-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 2.1 mm
582711-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 1 mm
53819-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 7.5 cm × 4.6 mm
53822-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 2.1 mm
53829-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 4.6 mm
53826-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 4.6 mm
53827-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 10 cm × 4.6 mm
466123
Sigma-Aldrich
Phosphoric acid, crystalline, ≥99.999% trace metals basis
53804-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 7.5 cm × 2.1 mm
47848
Supelco
Potassium Sorbate, analytical standard
53818-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 3 cm × 4.6 mm
53992-U
Supelco
Ascentis® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 300 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