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

초록

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

제품 번호

브랜드

제품 설명

717975

Sigma-Aldrich

Methanol, suitable for NMR (reference standard)

322415

Sigma-Aldrich

Methanol, anhydrous, 99.8%

359769

Sigma-Aldrich

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

576956

Sigma-Aldrich

Acetonitrile solution, contains 0.1 % (v/v) formic acid, suitable for HPLC

612162

Sigma-Aldrich

Phosphoric acid solution, suitable for NMR (reference standard), 85% in D₂O (99.9 atom % D), NMR tube size 4.2 mm × 8 in. , WGS-5BL Coaxial NMR tube

574732

Sigma-Aldrich

Acetonitrile solution, contains 0.1 % (v/v) trifluoroacetic acid, suitable for HPLC

574724

Sigma-Aldrich

Acetonitrile solution, contains 0.05 % (v/v) trifluoroacetic acid

W290017

Sigma-Aldrich

Phosphoric acid solution, 85 wt. % in H₂O, FCC, FG

699608

Sigma-Aldrich

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

698822

Sigma-Aldrich

Phosphoric acid solution, suitable for NMR (reference standard), 85% in D₂O (99.9 atom % D), NMR tube size 5 mm × 8 in.

650609

Sigma-Aldrich

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

494437

Sigma-Aldrich

Methanol, BioReagent, ≥99.93%

50812-U

Supelco

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

50813-U

Supelco

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

PHR1372

Supelco

Methanol, Pharmaceutical Secondary Standard; Certified Reference Material

50814-U

Supelco

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

PHR1320

Supelco

Residual Solvent - Acetonitrile(solution in DMSO), Pharmaceutical Secondary Standard; Certified Reference Material

24229

Sigma-Aldrich

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

34885

Sigma-Aldrich

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

646377

Sigma-Aldrich

Methanol, HPLC Plus, ≥99.9%

34860

Sigma-Aldrich

Methanol, suitable for HPLC, ≥99.9%

439193

Sigma-Aldrich

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

50507-U

Supelco

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

50526-U

Supelco

Ascentis^® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 10 cm × 3 mm

50533-U

Supelco

Ascentis^® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 7.5 cm × 4.6 mm

50523-U

Supelco

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

50522-U

Supelco

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

50529-U

Supelco

Ascentis^® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 3 cm × 4.6 mm

50537-U

Supelco

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