Volume : 11, Issue : 09, September – 2024
Title:
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DOMPERIDONE IN BULK AND TABLET DOSAGE FORM
Authors :
Jerrypothula Pranitha, Koppu Udaya Bhanu Sri*, Dr.D. Venkata Ramana, Dr. Gadipally Sai Kiran
Abstract :
The development and validation of a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of domperidone in bulk and tablet dosage forms are presented. The aim of this study was to establish a precise, accurate, and reliable RP-HPLC method that meets regulatory standards for the quantification of domperidone. The analytical method was developed using a Waters HPLC system equipped with an auto-sampler and a PDA 996 detector. Chromatographic separation was achieved on a Symmetry ODS C18 column (4.6 × 150 mm, 5 µm) at a column temperature of 35ºC. The mobile phase comprised a mixture of methanol and acetone in a ratio of 35:65% (v/v), with a flow rate of 1.0 mL/min and a detection wavelength of 236 nm. The injection volume was 10 µL, and the total run time for each analysis was 6 minutes.
The method was thoroughly validated following ICH guidelines, assessing parameters such as specificity, linearity, accuracy, precision, and robustness. Results demonstrated that the RP-HPLC method is both effective and reliable for the simultaneous estimation of domperidone in bulk and tablet forms. The method exhibited high specificity and sensitivity with a good resolution of domperidone from excipients. The developed RP-HPLC method is suitable for routine quality control and analytical purposes in pharmaceutical applications, ensuring compliance with industry standards.
Keywords: Reverse Phase High-Performance Liquid Chromatography, Domperidone.
Cite This Article:
Please cite this article in press Koppu Udaya Bhanu Sri et al Development And Validation Of RP-HPLC Method For The Simultaneous Estimation Of Domperidone In Bulk And Tablet Dosage Form..,Indo Am. J. P. Sci, 2024; 11 (9).
Number of Downloads : 10
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