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  • 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
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

USP
Methyl alcohol, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Methanol solution, (Methanol:Dimethyl sulfoxide 1:1 (v/v))
Sigma-Aldrich
Phosphoric acid, ACS reagent, ≥85 wt. % in H2O
Sigma-Aldrich
Acetonitrile, ReagentPlus®, 99%
Sigma-Aldrich
Phosphoric acid, puriss. p.a., crystallized, ≥99.0% (T)
Sigma-Aldrich
Acetonitrile, ≥99.9% (GC)
Sigma-Aldrich
Phosphoric acid, puriss., meets analytical specification of Ph. Eur., BP, NF, FCC, 85.0-88.0%
Sigma-Aldrich
Acetonitrile, suitable for DNA synthesis, ≥99.9% (GC)
Sigma-Aldrich
Acetonitrile, ≥99.5% (GC)
Sigma-Aldrich
Acetonitrile, biotech. grade, ≥99.93%
Sigma-Aldrich
Acetonitrile, ACS reagent, ≥99.5%
Sigma-Aldrich
Phosphoric acid, ACS reagent, ≥85 wt. % in H2O
Sigma-Aldrich
Acetonitrile, electronic grade, 99.999% trace metals basis
Supelco
Potassium sorbate, certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
Supelco
Ascentis® Express C18 PCP HPLC Columns, 2.7 μm particle size, L × I.D. 15 cm × 4.6 mm
Supelco
Ascentis® Express C18 PCP HPLC Columns, 2.7 μm particle size, L × I.D. 10 cm × 4.6 mm
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 10 mm
Supelco
Potassium sorbate, Pharmaceutical Secondary Standard; Certified Reference Material
Potassium sorbate, European Pharmacopoeia (EP) Reference Standard
USP
Residual Solvent Class 2 - Acetonitrile, United States Pharmacopeia (USP) Reference Standard
USP
Potassium sorbate, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Phosphoric acid, BioUltra, ≥85% (T)
Sigma-Aldrich
Potassium sorbate, purum p.a., ≥99.0% (NT)
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 3 cm × 2.1 mm
Sigma-Aldrich
Phosphoric acid, ≥85 wt. % in H2O, ≥99.999% trace metals basis
Sigma-Aldrich
Acetonitrile, anhydrous, 99.8%
Supelco
Acetonitrile, analytical standard
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 3 mm
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 3 cm × 3 mm
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 7.5 cm × 2.1 mm