A. Chauhan 1*, P. K. Arora 2, A. Yadav 2, R. M. Singh 2, D. K. Sharma 2, S. C. Mathur 2, G. N. Singh 2
- Indian Pharmacopoeial Laboratory, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Govt, of India, Sector -23, Rajnagar, Ghaziabad - 201002, India
- Indian Pharmacopoeial Laboratory, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Govt, of India, Sector -23, Rajnagar, Ghaziabad- 201002, India
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 GF254 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 R2 = 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 (Rf) 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.
