Method Development and Validation of Famotidine Oral Suspension by RP-HPLC Method

Abstract

For perseverance of Famotidine a simple, fast and selective procedure were developed in drug substance and its pharmaceutical preparations. In the proposed project, a successful attempt has been made to develop a simple, accurate, economic and rapid method for the estimation and to validate the method. As a result, a simple, economical, precise and accurate method was developed and validated by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). The main objective for that is to improve the conditions and parameters, which should be followed in the development and validation. The developed Reverse phase HPLC technique was done utilizing filtered and degassed pH-6.0 Acetate buffer as a Mobile phase-A and pH-6.0 Acetate buffer and organic mixture in the ratio of 30:70 as a Mobile phase-B. By using waters X-Bridge C₁₈ (150*4.6mm), 3.5µm column chromatographic separation was achieved. The flow rate and run time was 0.8mL/min and 45minutes. The detection wavelength was 265nm.The average percentage recovery for Famotidine related compound-C was found to be 94.3%, 95.9%, 96.0% represents the accuracy of the method and for Famotidine related compound-D was found to be 95.8, 95.4 and 96.4. The %RSD for Famotidine related compound-C was found to be 5.576 and for Famotidine related compound-D was found to be 1.588 represents the precision of the method. The correlation coefficient square for Famotidne, Famotidine related compound-C and Famotidine related compound-D was found to be 0.999999, 0.9992 and 0.9991 respectively. Respective parameters met the acceptance criteria, from the results concluded that the developed method was precise and accurate.