Nitazoxanide is a novel broad-spectrum antiparasitic agent. The present paper describes stability-indicating reverse phase thin-layer chromatography (RP-TLC) assay method for nitazoxanide in bulk and pharmaceutical formulations.The method employed TLC aluminium plates precoated with silica gel 60 RP-18 F-254 S as the stationary phase. The solvent system consisted of acetone: water: acetic acid (4:2:0.2 v/v). The system was found to give compact spot for nitazoxanide (Rf value of 0.52 ± 0.02). The UV densitometric detection was carried out at λ = 345 nm. The method showed high sensitivity with good linearity over the concentration range 200 – 1200 ng spot -1.
The mean values ± S.D of correlation coefficient, slope and intercept were r2 = 0.9992 ± 0.0001, 9.3726 ± 0.023, and 3795.46 ± 13.940 with respect to peak area. The developed RP-TLC method was validated with respect to accuracy, precision, recovery and robustness. The developed method can also be conveniently used for the assay determination of nitazoxanide in pharmaceutical formulations. The limits of detection and quantitation were 17.12 and 51.88 ng spot -1, respectively.
Nitazoxanide was subjected to acid and alkali hydrolysis, oxidation, photochemical and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and heat conditions. This indicates that the drug is susceptible to acid, base hydrolysis, oxidation and heat. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of said drug. The proposed developed RP-TLC method can be applied for identification and quantitative determination of nitazoxanide in bulk drug and tablet formulation.
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