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

50813-U

Supelco

Ascentis^® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 10 cm × 2.1 mm

50819-U

Supelco

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

50805-U

Supelco

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

50809-U

Supelco

Ascentis^® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 3 cm × 2.1 mm

50811-U

Supelco

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

50812-U

Supelco

Ascentis^® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 7.5 cm × 2.1 mm

50814-U

Supelco

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

50816-U

Supelco

Ascentis^® Express C18, 2 μm UHPLC Column, 2 μm particle size, L × I.D. 5 cm × 3 mm

PHR1372

Supelco

Methanol, Pharmaceutical Secondary Standard; Certified Reference Material

M1775

Sigma-Aldrich

Methanol, Absolute - Acetone free

179337

Sigma-Aldrich

Methanol, ACS reagent, ≥99.8%

676780

Sigma-Aldrich

Methanol, ACS reagent, ≥99.8%

320390

Sigma-Aldrich

Methanol, ACS reagent, ≥99.8%

24229

Sigma-Aldrich

Methanol, puriss., meets analytical specification of Ph Eur, ≥99.7% (GC)

494437

Sigma-Aldrich

Methanol, BioReagent, ≥99.93%

32213

Sigma-Aldrich

Methanol, puriss. p.a., ACS reagent, reag. ISO, reag. Ph. Eur., ≥99.8% (GC)

154903

Sigma-Aldrich

Methanol, ACS spectrophotometric grade, ≥99.9%

179957

Sigma-Aldrich

Methanol, Laboratory Reagent, ≥99.6%

646377

Sigma-Aldrich

Methanol, HPLC Plus, ≥99.9%

34885

Sigma-Aldrich

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

439193

Sigma-Aldrich

Methanol, suitable for HPLC, gradient grade, suitable as ACS-grade LC reagent, ≥99.9%

34860

Sigma-Aldrich

Methanol, suitable for HPLC, ≥99.9%

19-2450

Sigma-Aldrich

Methanol, JIS 300, ≥99.8%, for residue analysis

19-2420

Sigma-Aldrich

Methanol, SAJ first grade, ≥99.5%

19-2410

Sigma-Aldrich

Methanol, JIS special grade, ≥99.8%

717975

Sigma-Aldrich

Methanol, NMR reference standard

679186

Sigma-Aldrich

Acetonitrile solution, contains 0.05 % (w/v) ammonium formate, 5 % (v/v) water, 0.1 % (v/v) formic acid, suitable for HPLC

19-2400

Sigma-Aldrich

Methanol, SAJ special grade

19-2470

Sigma-Aldrich

Methanol, suitable for HPLC

699608

Sigma-Aldrich

Phosphoric acid solution, NMR reference standard, 85% in D₂O (99.9 atom % D), NMR tube size 3 mm × 8 in.