Abstract
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF DAPSONE

Santosh V. Gandhi* and Gaurav R. Patil

ABSTRACT

A simple, precise and sensitive stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the analysis of Dapsone in bulk and in tablet dosage form. The separation was performed on pre-coated silica gel 60 GF254 plates using Toluene: Ethyl acetate (5:5 v/v) as mobile phase. The retention factor (Rf) was found to be 0.38. The detection of band was carried out at 295 nm.The drug was subjected to different stress conditions like acid, base hydrolysis, oxidation, thermal degradation and photolysis. The method was successfully validated according to ICH Q2 (R1) guidelines. The linear regression analysis data for the calibration plot showed good linear relationship with R2 =0.9534 in the range of 200-1200 ng band-1. The method found to be accurate as results of the recovery studies are close to the 100 %. The developed method can be adopted for routine analysis of Dapsone in bulk and pharmaceutical dosage form.

Keywords: High performance thin layer chromatography (HPTLC), Dapsone, method validation, stability indicating method.


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