Validated Method Development for the Estimation of Domperidone by UV- Spectroscopy
Shradha Chauhan, Praveen Kumar, Preeti Kothiyal, Shri Guru, Ram Rai
Abstract
Shradha Chauhan, Praveen Kumar, Preeti Kothiyal, Shri Guru, Ram Rai
Abstract
The present work represents a UV spectrophotometric method for the estimation of domperidone in bulk and tablet dosage form. Methanol was used as solvent. Domperidone exhibit absorption maxima at 285 nm. The developed method obeyed Beer-Lambert’s law in the concentration range of 5-20μg/ml having line equation Y= 0.277x-0.025 with correlation coefficient of 0.999. There is no interference from any common pharmaceutical excipients. The precision of method was determined by performing repeatability study, intra-day study and inter-day study. The accuracy of the method was confirmed by recovery studies from tablets at three different levels of standard additions. Results of the analysis were validated statistically and by recovery study. The analytical method was validated for various parameters as per ICH (International Conference on Harmonization) guidelines. The proposed method was found to be simple, rapid, accurate and precise and can be applied for the routine quality control studies for assay of Domperidone in bulk and tablet dosage forms.
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The present work represents a UV spectrophotometric method for the estimation of domperidone in bulk and tablet dosage form. Methanol was used as solvent. Domperidone exhibit absorption maxima at 285 nm. The developed method obeyed Beer-Lambert’s law in the concentration range of 5-20μg/ml having line equation Y= 0.277x-0.025 with correlation coefficient of 0.999. There is no interference from any common pharmaceutical excipients. The precision of method was determined by performing repeatability study, intra-day study and inter-day study. The accuracy of the method was confirmed by recovery studies from tablets at three different levels of standard additions. Results of the analysis were validated statistically and by recovery study. The analytical method was validated for various parameters as per ICH (International Conference on Harmonization) guidelines. The proposed method was found to be simple, rapid, accurate and precise and can be applied for the routine quality control studies for assay of Domperidone in bulk and tablet dosage forms.
Key concepts: Domperidone, Repeatability, Beer–Lambert law, Dosage form, Ultraviolet visible spectroscopy, Solvent, Chromatography, Materials science