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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
53799-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 2 cm × 2.1 mm, pk of 1 ea
Pricing and availability is not currently available.
53793-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 15 cm × 10 mm, pk of 1 ea
Pricing and availability is not currently available.
53819-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 7.5 cm × 4.6 mm, pk of 1 ea
Pricing and availability is not currently available.
53812-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 7.5 cm × 3 mm, pk of
Pricing and availability is not currently available.
53816-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 15 cm × 3 mm, pk of 1 ea
Pricing and availability is not currently available.
53818-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 3 cm × 4.6 mm, pk of 1 ea
Pricing and availability is not currently available.
53814-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 10 cm × 3 mm, pk of
Pricing and availability is not currently available.
582711-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 5 cm × 1 mm, pk of 1 ea
Pricing and availability is not currently available.
53822-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 5 cm × 2.1 mm, pk of 1 ea
Pricing and availability is not currently available.
53823-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 10 cm × 2.1 mm, pk of 1 ea
Pricing and availability is not currently available.
53825-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 15 cm × 2.1 mm, pk of 1 ea
Pricing and availability is not currently available.
53827-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 10 cm × 4.6 mm, pk of 1 ea
Pricing and availability is not currently available.
53826-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 5 cm × 4.6 mm, pk of 1 ea
Pricing and availability is not currently available.
53829-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 15 cm × 4.6 mm, pk of 1 ea
Pricing and availability is not currently available.
609781
Sigma-Aldrich
Phosphoric acid-16O4 solution, 70 wt. % in D2O, 99.9 atom % 16O
Pricing and availability is not currently available.
53501-U
Supelco
Ascentis® Express C18, 2.7 Micron Guard Cartridge, 2.7 μm particle size, L × I.D. 5 mm × 2.1 mm, pkg of 3 ea
Pricing and availability is not currently available.
53504-U
Supelco
Ascentis® Express C18, 2.7 Micron Guard Cartridge, 2.7 μm particle size, L × I.D. 5 mm × 3 mm, pkg of 3 ea
Pricing and availability is not currently available.
53508-U
Supelco
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
Pricing and availability is not currently available.
53802-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 3 cm × 2.1 mm, pk of 1 ea
Pricing and availability is not currently available.
53811-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 5 cm × 3 mm, pk of 1 ea
Pricing and availability is not currently available.
53804-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 7.5 cm × 2.1 mm, pk of 1 ea
Pricing and availability is not currently available.
53805-U
Supelco
Ascentis® Express C18 (2.7 μm) HPLC Column, L × I.D. 3 cm × 3 mm, pk of 1 ea
Pricing and availability is not currently available.
85520
Sigma-Aldrich
Potassium sorbate, purum p.a., ≥99.0% (NT)
Pricing and availability is not currently available.
40430
Supelco
Potassium sorbate, certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
Pricing and availability is not currently available.
P5811
Sigma-Aldrich
Phosphoric acid, BioReagent, suitable for insect cell culture, 85%
Pricing and availability is not currently available.
733466
Sigma-Aldrich
Acetonitrile, electronic grade, 99.999% trace metals basis
Pricing and availability is not currently available.
1601340
USP
Residual Solvent Class 2 - Acetonitrile, United States Pharmacopeia (USP) Reference Standard
Pricing and availability is not currently available.
34881
Sigma-Aldrich
Acetonitrile, suitable for HPLC-GC, ≥99.8% (GC)
Pricing and availability is not currently available.
04107
Sigma-Aldrich
Phosphoric acid, puriss., meets analytical specification of Ph. Eur., BP, NF, FCC, 85.0-88.0%
Pricing and availability is not currently available.
30417
Sigma-Aldrich
Phosphoric acid, puriss. p.a., ACS reagent, reag. ISO, reag. Ph. Eur., ≥85%
Pricing and availability is not currently available.