Журнал хроматографии и методов разделения

Журнал хроматографии и методов разделения
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ISSN: 2157-7064


Development of a Validated Stability- Indicating HPTLC Method for Nitazoxanide in Pharmaceutical Formulation

Keyur B.Ahir, Emanuel M. Patelia and Falgun A.Mehta

The present paper describes stability indicating high-performance thin-layer chromatography (HPTLC) assay method for nitazoxanide in bulk drugs. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of carbon tetra chloride: ethyl acetate (7:3 v/v). The system was found to give compact spot for nitazoxanide (Rf value of ± 0.02). Densitometric analysis of nitazoxanide was carried out in the absorbance mode at 345 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9992 ± 0.0001 with respect to peak area in the concentration range 200 - 1200 ng spot-1. The mean value ± S.D. of slope and intercept were 9.3726 ± 0.023 and 3795.46 ± 13.940 with respect to peak area. The developed HPTLC method was validated with respect to accuracy, precision, recovery and robustness. Also to determine related substance and assay determination of nitazoxanide that can be used to evaluate the quality of regular production samples. 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 HPTLC method can be applied for identification and quantitative determination of nitazoxanide in bulk drug and tablet formulation.