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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
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
53823-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 10 cm × 2.1 mm
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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
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606723
Sigma-Aldrich
Methanol-12C, 99.95 atom % 12C
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53829-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 4.6 mm
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53827-U
Supelco
Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 10 cm × 4.6 mm
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53816-U
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Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 3 mm
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53508-U
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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
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53814-U
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Ascentis® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 10 cm × 3 mm
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85520
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Potassium sorbate, purum p.a., ≥99.0% (NT)
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79617
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45983
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Acetonitrile, analytical standard
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466123
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Phosphoric acid, crystalline, ≥99.999% trace metals basis
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452289
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Phosphoric acid, ≥85 wt. % in H2O, ≥99.999% trace metals basis
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437557
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Acetonitrile, ≥99.5%, ACS reagent
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345245
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Phosphoric acid, 85 wt. % in H2O, 99.99% trace metals basis
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271004
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Acetonitrile, anhydrous, 99.8%
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P5811
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40430
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733466
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Acetonitrile, electronic grade, 99.999% trace metals basis
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609781
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50462-U
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Ascentis® Express C18 PCP HPLC Columns, 2.7 μm particle size, L × I.D. 15 cm × 4.6 mm
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695017
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Phosphoric acid, ACS reagent, ≥85 wt. % in H2O
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04107
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Phosphoric acid, puriss., meets analytical specification of Ph. Eur., BP, NF, FCC, 85.0-88.0%
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30417
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Phosphoric acid, puriss. p.a., ACS reagent, reag. ISO, reag. Ph. Eur., ≥85%
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34442
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Acetonitrile, suitable for DNA synthesis, ≥99.9% (GC)
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60004
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494445
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438081
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Phosphoric acid, ACS reagent, ≥85 wt. % in H2O
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33019
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Acetonitrile, puriss. p.a., ACS reagent, reag. Ph. Eur., ≥99.5% (GC)
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360457
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