Paper Contents
Abstract
A reliable and efficient Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method has been developed and validated for the simultaneous estimation of Ranitidine and Magaldrate in bulk and tablet dosage forms. The chromatographic separation was achieved using a Phenomenex Luna C18 column (4.6 250 mm, 5 m) with a mobile phase composed of methanol and water in a ratio of 65:35 (vv). The column temperature was maintained at 35C, and the detection wavelength was set at 220 nm. The method utilized a flow rate of 1.0 mLmin and an injection volume of 10 L. The total run time for the analysis was 7 minutes. The method was validated according to ICH guidelines, demonstrating robust performance across several critical parameters. Specificity was confirmed by the absence of interference from excipients. Linearity was established with correlation coefficients exceeding 0.999 for both Ranitidine and Magaldrate. Accuracy was verified through recovery studies, achieving mean recovery rates within acceptable ranges. Precision studies showed intra-day and inter-day RSD values below 2%, indicating high reproducibility. The limits of detection and quantification were satisfactorily low, allowing for sensitive detection of both compounds.The validated RP-HPLC method is effective for the routine analysis of Ranitidine and Magaldrate in both bulk substances and tablet formulations, offering a precise and efficient tool for quality control and assurance in pharmaceutical analysis.
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Copyright © 2024 mounika. This is an open access article distributed under the Creative Commons Attribution License.
