Development and Validation of HPTLC Method for the Estimation of Ondansetron Hydrochloride in Bulk Drug and Tablet Dosage Forms

Abstract

A simple, selective, precise and sensitive high performance thin-layer chromatographic (HPTLC) method has been developed and validated for the analysis of ondansetron hydrochloride both in bulk drug and in tablet dosage forms. The separation was performed on pre-coated silica gel 60 GF 254 plates using methanol:triethylamine:glacial acetic acid (9.5:0.5:0.1, v/v/v) as mobile phase. Densitometric analysis was performed in reflectance-absorbance mode at 309 nm. The linear regression analysis data for the calibration plot showed good linear relationship with R 2 = 0.998 ± 0.00047 in the range of 300-1100 ng spot -1 . The minimum amount of ondansetron hydrochloride that could be detected and quantified was 54.60 and 165.46 ng spot -1 respectively. The mean retardation factor (R f ) for ondansetron hydrochloride was found to be 0.77 ± 0.01. The developed method was validated according to International Conference on Harmonization (ICH) guidelines for specificity, linearity, range, accuracy, precision, detection limit, quantitation limit and robustness etc.