Abstract
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.
Highlights
The chemical designation of nitazoxanide is [2- [(5-nitro-1, 3-thiazol-2-yl) carbamoyl] phenyl] ethanoate and used as antiprotozoal and anthelmintic agent (Figure 1) [1]
This paper mainly deals with the forced degradation of nitazoxanide under stress conditions like acid hydrolysis, base hydrolysis, peroxide hydrolysis, heat and light
It was observed that prewashing of TLC plates with methanol and presaturation of TLC chamber with mobile phase for 15 min ensure good reproducibility and peak shape of nitazoxanide
Summary
The chemical designation of nitazoxanide is [2- [(5-nitro-1, 3-thiazol-2-yl) carbamoyl] phenyl] ethanoate and used as antiprotozoal and anthelmintic agent (Figure 1) [1]. Validated stability indicating HPLC method for separation of nitazoxanide from its impurities was published [7]. The main intention of the work is to build up a stability indicating high-performance thinlayer chromatography for determination of nitazoxanide. The samples were spotted in the form of bands of width 6 mm with Camag microlitre syringe on precoated silica gel aluminium Plate 60F254 Linear ascending development was carried out in twin trough glass chamber saturated with mobile phase. Subsequent to the development; TLC plates were dried in current of air with the help of an air dryer. Calibration spots were applied on TLC plate using the stock solution, to enable application of 200 to 1200 ng spot for nitazoxanide. The plate was developed on previously described mobile phase. The peak areas were plotted against corresponding concentrations to obtain the calibration graphs
Sign-in/Register to view highlights & summary 
Published Version
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call