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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
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
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)
179957
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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%
717975
Sigma-Aldrich
Methanol, NMR reference standard
699608
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Phosphoric acid solution, NMR reference standard, 85% in D2O (99.9 atom % D), NMR tube size 3 mm × 8 in.
698822
Sigma-Aldrich
Phosphoric acid solution, NMR reference standard, 85% in D2O (99.9 atom % D), NMR tube size 5 mm × 8 in.
82762
Supelco
Methanol, analytical standard
322415
Sigma-Aldrich
Methanol, anhydrous, 99.8%
612162
Sigma-Aldrich
Phosphoric acid solution, NMR reference standard, 85% in D2O (99.9 atom % D), NMR tube size 4.2 mm × 8 in. , WGS-5BL Coaxial NMR tube
W290017
Sigma-Aldrich
Phosphoric acid solution, 85 wt. % in H2O, FCC, FG
359769
Sigma-Aldrich
trans,trans-2,4-Hexadienoic acid potassium salt, ReagentPlus®, 99%
50518-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 15 cm × 2.1 mm
50525-U
Supelco
Ascentis® Express C18, 5 μm HPLC Column, 5 μm particle size, L × I.D. 7.5 cm × 3 mm