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Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
45, Number 8, September 2007, pp. 531-536
Validated HPTLC Method for Simultaneous Estimation
of Levofloxacin Hemihydrate and Ornidazole in Pharmaceutical
Dosage Form
S.B. Chepurwar, A.A. Shirkhedkar, S.B. Bari,
R.A. Fursule, and S.J. Surana
Department of Pharmaceutical Analytical Chemistry, R.C. Patel
College of Pharmacy, Shirpur, Dist-Dhule, Maharashtra State,
India 425 405
A simple, rapid, and accurate high-performance
thin-layer chromatography (HPTLC) method is described for the
simultaneous determination of levofloxacin hemihydrate and ornidazole
in tablet dosage form. The method is based on the HPTLC separation
of the two drugs followed by densitometric measurements of their
spots at 298 nm. The separation is carried out on Merck TLC aluminium
sheets of silica gel 60 F254 using n-butanol–methanol–ammonia
(5:1:1.5, v/v/v) as mobile phase. The linearity is found to be
in the range of 50–250 and 100–500 ng/spot for levofloxacin
hemihydrate and ornidazole, respectively. The method is successively
applied to pharmaceutical formulation because no chromatographic
interferences from the tablet excipients are found. The suitability
of this HPTLC method for the quantitative determination of the
compounds is proved by validation in accordance with the requirements
laid down by International Conference on Harmonization (ICH)
guidelines.
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