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

609781

Sigma-Aldrich

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

47848

Supelco

Potassium Sorbate, analytical standard

53992-U

Supelco

Ascentis^® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 300 μm

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

54271-U

Supelco

Ascentis^® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 300 μm

675415

Sigma-Aldrich

Acetonitrile, HPLC Plus, ≥99.9%, poly-coated bottles

437557

Sigma-Aldrich

Acetonitrile, ≥99.5%, ACS reagent

1548407

USP

Potassium sorbate, United States Pharmacopeia (USP) Reference Standard

P2650000

Potassium sorbate, European Pharmacopoeia (EP) Reference Standard

50387

Supelco

Acetonitrile, suitable for HPLC, gradient grade, ≥99.9% (GC)

04102

Sigma-Aldrich

Phosphoric acid, puriss., ≥99%

53802-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 3 cm × 2.1 mm

53805-U

Supelco

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

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

53793-U

Supelco

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

53823-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 10 cm × 2.1 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

53811-U

Supelco

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

53998-U

Supelco

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

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

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

53816-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 3 mm

494445

Sigma-Aldrich

Acetonitrile, biotech. grade, ≥99.93%

271004

Sigma-Aldrich

Acetonitrile, anhydrous, 99.8%

45983

Supelco

Acetonitrile, analytical standard

34851

Sigma-Aldrich

Acetonitrile, suitable for HPLC, gradient grade, ≥99.9%