Development and Validation of Spectrophotometric and Chromatographic Stability Indicating Methods for Quantification of Tinidazole and Domperidone Drugs

Abstract

Simple, accurate, precise and economical UV spectrophotometric methods for estimation of tinidazole and domperidone have been developed and validated. The wavelengths of maximum absorbance selected for tinidazole and domperidone were 317 and 284 nm, respectively. Tinidazole and domperidone showed linearity at the selected wavelength and obeyed Beer’s law in the concentration range of 3.0-30 and 4.8-48 µg/mL with correlation coefficient of 0.9997 and 0.9997, respectively. Recovery percentage of tinidazole and domperidone was obtained in the range of 98.78% -100.72% and 98.94% -101.71%, respectively, confirming the accuracy of the proposed methods. The methods showed good reproducibility and recovery with RSD percentage less than 2. Liquid chromatographic methods for estimation of tinidazole and domperidone were been also developed and validated. For tinidazole, the mobile phase used was composed of phosphate buffer: methanol (50:50, v: v), flowing at a rate of 0.5 mL/min, at wavelength 317 nm,through column C18 (250 x 4.6 mm, 5µm particle size). Tinidazole showed linearity at the selected wavelength and obeyed Beer’s law in the concentration range of 3.2-40.0 µg/mL, with correlation coefficient of 0.9999. The method gave recovery of 99.10-102.45 %. For domperidone, the mobile phase used was composed of Phosphoric acid 1%: methanol: acetonitrile (100: 25:25) (v: v: v), flowing at a rate of 1.0 mL/min, at wavelength 284 nm,through column C18 (100 x 4.6 mm, 5µm, particle size). Domperidone showed linearity at the selected wavelength and obeyed Beer’s law in the concentration range of 9.6 - 48 µg/mL with correlation coefficient of 0.9998. The method gave a recovery of 99.31% - 102.81 %. The recovery results for both developed chromatographic methods for each drug were highly accurate. Stability studies of both drugs were affected by sunlight revealed that the method could be used as stability indicating method for the routine analysis of drug in commercial tablets.