Abstract
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF ONDANSETRON HYDROCHLORIDE

Santosh V. Gandhi* and Madhuri S. Rathi

ABSTRACT

A simple, precise and sensitive stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the analysis of Ondansetron Hydrochloride both in bulk and in tablet dosage form. The seperation was performed on pre-coated silica gel 60 GF254 plates using ethyl acetate: methanol (6:4 v/v) as mobile phase. The retention factor (Rf) was found to be 0.43 ± 0.07. The detection of band was carried out at 248 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 = 0.9928 in the range 500-3000 ng/band. The method found to be accurate as results of the recovery studies are close to the 100%. The developed method was found to be simple, sensitive, selective, accurate and repeatable for analysis of ondansetron hydrochloride and can be adopted for routine analysis of drug in bulk and pharmaceutical dosage form.

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


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