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

85520

Sigma-Aldrich

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

79617

Sigma-Aldrich

Phosphoric acid, BioUltra, ≥85% (T)

45983

Supelco

Acetonitrile, analytical standard

P5811

Sigma-Aldrich

Phosphoric acid, BioReagent, suitable for insect cell culture, 85%

582711-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 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

53825-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 2.1 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

47848

Supelco

Potassium Sorbate, analytical standard

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

53998-U

Supelco

Ascentis^® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 500 μm

53793-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 10 mm

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

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

733466

Sigma-Aldrich

Acetonitrile, electronic grade, 99.999% trace metals basis

54273-U

Supelco

Ascentis^® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 500 μm

53816-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 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

53818-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 3 cm × 4.6 mm

609781

Sigma-Aldrich

Phosphoric acid-¹⁶O₄ solution, 70 wt. % in D₂O, 99.9 atom % ¹⁶O

53826-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 4.6 mm

345245

Sigma-Aldrich

Phosphoric acid, 85 wt. % in H₂O, 99.99% trace metals basis

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

271004

Sigma-Aldrich

Acetonitrile, anhydrous, 99.8%

53811-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 3 mm

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