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

PHR1551

Supelco

Acetonitrile, Pharmaceutical Secondary Standard; Certified Reference Material

53799-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 2 cm × 2.1 mm

53825-U

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53819-U

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Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 7.5 cm × 4.6 mm

606723

Sigma-Aldrich

Methanol-¹²C, 99.95 atom % ¹²C

47848

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Potassium Sorbate, analytical standard

53793-U

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Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 10 mm

53992-U

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Ascentis^® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 300 μm

53998-U

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Ascentis^® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 5 cm × 500 μm

54271-U

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Ascentis^® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 300 μm

54273-U

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Ascentis^® Express C18, 2.7 Micron Capillary HPLC Column, 2.7 μm particle size, L × I.D. 15 cm × 500 μm

53814-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 10 cm × 3 mm

53818-U

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Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 3 cm × 4.6 mm

53812-U

Supelco

Ascentis^® Express C18, 2.7 μm HPLC Column, 2.7 μm particle size, L × I.D. 7.5 cm × 3 mm

721956

Sigma-Aldrich

Methanol solution, NMR reference standard, 4% in methanol-d₄ (99.8 atom % D), NMR tube size 3 mm × 8 in.

P2650000

Potassium sorbate, European Pharmacopoeia (EP) Reference Standard

632546

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Methanol solution, contains 0.10 % (v/v) formic acid, UHPLC, suitable for mass spectrometry (MS), ≥99.5%

733466

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85520

Sigma-Aldrich

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437557

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1424109

USP

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60004

Sigma-Aldrich

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110086

Sigma-Aldrich

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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

PHR1278

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50461-U

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Ascentis^® Express C18 PCP HPLC Columns, 2.7 μm particle size, L × I.D. 10 cm × 4.6 mm

34442

Sigma-Aldrich

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V800024

Sigma-Aldrich

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1548407

USP

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53504-U

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Ascentis^® Express C18, 2.7 Micron Guard Cartridge, 2.7 μm particle size, L × I.D. 5 mm × 3 mm, pkg of 3 ea