Development and Validation of Stability-indicating HPLC Method for Betamethoasone Dipropionate and Related Substances in Topical Formulation.

Abstract:

:A gradient reversed phase HPLC method was developed and validated for analysis of betamethasone dipropionate, its related substances and degradation products, using Altima C(18) column (250×4.6 mm, 5 μm) with a flow rate of 1.0 ml/min and detection wavelength of 240 nm. The mobile phase A is a mixture of water, tetrahydrofuran and acetonitrile in the ratio of 90:4:6 (v/v/v) while mobile phase B is a mixture of acetonitrile, tetrahydrofuran, water and methanol in the ratio of 74:2:4:20 (v/v/v/v). The samples were analyzed using 20 μl injection volume and the column temperature was maintained at 50°. The limit of detection and limit of quantitation were found to be 0.02 μg/ml and 0.07 μg/ml, respectively. The stability-indicating capability of method was established by forced degradation studies and method demonstrated successful separation of drug, its related substances and degradation products. The method was validated as per the International Conference on Harmonization guidelines. The developed method is linear in the range of 0.07 to 200% of specification limits established for all the known related substances; betamethasone17-propionate, betamethasone 21-propionate, betamethasone 17-propionate-21-acetate (RSD <5, 2, 1%, respectively, r(2)=09991-0.9999 for sample concentration of 100 μg/ml). The method is sensitive, specific, linear, accurate, precise and stability indicating for the quantitation of drug, its related substances and other degradation compounds.

journal_name

Indian J Pharm Sci

authors

Vairale AS,Sivaswaroop P,Bandana S

doi

10.4103/0250-474X.103840

subject

Has Abstract

pub_date

2012-03-01 00:00:00

pages

107-15

issue

2

eissn

0250-474X

issn

1998-3743

pii

IJPhS-74-107

journal_volume

74

pub_type

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