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A Validated Reversed Phase HPLC-Method for the Determination of Aceclofenac and Tizanidine in Tablets
A new simple, accurate, precise and reproducible Reverse Phase-High Performance Liquid Chromatographic method has been developed for the simultaneous estimation of Aceclofenac and Tizanidine in tablet dosage forms using C18 column (Ineretsil, 250 x 4.6 mm, 5 μm) in isocratic mode. The mobile phase consisted of acetonitrile, methanol and 20 mM phosphate buffer adjusted to pH 3.5 in ratio of (40:30:30 v/v) with Ultraviolet-Visible detection at 230 nm. The method was linear over the concentration range for aceclofenac120-280 μg/ml and for tizanidine 2-40 μg/ml. The recoveries of Tizanidine and Aceclofenac were found to be in the range of 99.45-100.61% and 99.56-101.32% respectively. The validation of method was carried out using International Conference on Harmonization-guidelines. The described High Performance Liquid Chromatographic method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.
Keywords
Simultaneous Estimation, RP - HPLC, Aceclofenac, Tizanidine, ICH Guidelines.
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