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

RÉSUMÉ

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.

MATÉRIAUX

Numéro du produit

Marque

Description du produit

53829-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 15 cm × 4.6 mm, pk of 1 ea

53827-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 10 cm × 4.6 mm, pk of 1 ea

53826-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 5 cm × 4.6 mm, pk of 1 ea

53822-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 5 cm × 2.1 mm, pk of 1 ea

47848

Supelco

Sorbate de potassium, analytical standard

PHR1278

Supelco

Potassium sorbate, Pharmaceutical Secondary Standard; Certified Reference Material

53814-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 10 cm × 3 mm, pk of

53825-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 15 cm × 2.1 mm, pk of 1 ea

85520

Sigma-Aldrich

Potassium sorbate, purum p.a., ≥99.0% (NT)

53816-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 15 cm × 3 mm, pk of 1 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

50538-U

Supelco

Ascentis^® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 25 cm × 4.6 mm

50814-U

Supelco

Ascentis^® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 15 cm × 2.1 mm

53819-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 7.5 cm × 4.6 mm, pk of 1 ea

53823-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 10 cm × 2.1 mm, pk of 1 ea

50537-U

Supelco

Ascentis^® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 15 cm × 4.6 mm

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

50811-U

Supelco

Ascentis^® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 5 cm × 2.1 mm

53799-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 2 cm × 2.1 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

359769

Sigma-Aldrich

trans,trans-2,4-Hexadienoic acid potassium salt, ReagentPlus^®, 99%

1548407

USP

Potassium sorbate, United States Pharmacopeia (USP) Reference Standard

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

53811-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 5 cm × 3 mm, pk of 1 ea

50536-U

Supelco

Ascentis^® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 10 cm × 4.6 mm

P2650000

Sorbate de potassium, European Pharmacopoeia (EP) Reference Standard

50819-U

Supelco

Ascentis^® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 10 cm × 3 mm

40430

Supelco

Potassium sorbate, certified reference material, TraceCERT^®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

53802-U

Supelco

Colonne de CLHP Ascentis^® Express C18, 2,7 μm, L × I.D. 3 cm × 2.1 mm, pk of 1 ea