Journal of Pharmaceutical Research

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

Affiliations
1 Indian Pharmacopoeial Laboratory, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Govt, of India, Sector -23, Rajnagar, Ghaziabad - 201002, IN
2 Indian Pharmacopoeial Laboratory, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Govt, of India, Sector -23, Rajnagar, Ghaziabad- 201002, IN

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 (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.

Keywords

Ondansetron Hydrochloride, HPTLC, Method Validation.

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