Determination of Toltrazuril in Presence of Complete Alkaline Degradation Product by Rp-HPLC and TLC-Densitometric Methods

Abstract

Objective: Toltrazuril is veterinary medicine, which is extensively used as an antiprotozoal drug. This drug can be analyzed by two sensitive chromatographic, accurate, and reproducible methods that have been developed and validated for the determination of toltrazuril in the presence of its alkaline degradation product. Methods: The first method involves an RP–HPLC separation of the two components, successfully achieved using Eclipse XDB-C18 Column (4.6 x 150 mm, 5 µm), using a mixture of acetonitrile and water (60:40, v/v) as a mobile phase at a flow rate of 1.4 ml/min. quantification was done with UV detector at a wavelength 242 nm UV detection. The second method is based on the separation and quantification of toltrazuril and its alkaline degradation product by TLC-densitometry on TLC silica gel aluminum plates GF254, using dichloromethane: methanol (9.5:0.5, v/v) as the developing system followed by densitometric measurement at 242 nm UV detection. Results: For RP-HPLC linearity of toltrazuril over the concentration range of 12.5–75 µg/ml, the components were well resolved from each other with significant diverse Rt values of 6.17 and 8.62 min for toltrazuril and its degradation product, respectively. While in TLC-densitometry method, the linearity of toltrazuril over the concentration range 0.2-6 µg/spot and the studied components were well resolved from each other with significant different Rf values of 0.33 and 0.52 for toltrazuril and its alkaline degradation product, respectively. For both the developed and validated methods the %RSD was found to be less than 2% and the % recovery was found to be between [98-102 %]. Conclusion: Fortunately, effective separation of the drug from its degradation product was established, along with the determination of toltrazuril as a raw material and the marketed pharmaceutical formulation, such as suspension without any interference. Hence it can be used for routine analysis in various pharmaceutical industries.

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