Optimized and validated stability indicating RP-UPLC method for the determination of famotidine in pharmaceutical formulations

Abstract

Background

Famotidine (FMD) is a histamine H₂-receptor antagonist that inhibits stomach acid production, and it is commonly used in the treatment of peptic ulcer disease and gastro esophageal reflux disease. The main objective of the present investigation is to develop a rapid, precise and accurate stability indicating ultra performance liquid chromatographic method for the analysis of pharmaceutical formulations.

Methods

Waters-Alliance Ultra Performance Liquid Chromatographic system equipped with Auto Sampler, PDA detector, detection at a wavelength of 297 nm, Symmetry C18 (2.1 × 50 mm, 1.7 μm, Make: BEH) column and mobile phase of potassium dihydrogen phosphate buffer of pH = 7.0 and acetonitrile in the ratio 40:60 v/v at a flow rate of 0.2 per minute was used for the assay of famotidine in tablets by a reverse phase ultra performance liquid chromatographic method (RP-UPLC).

Results and discussion

The system suitable parameters such as tailing factor and theoretical plate count were found to 1.48 and 8896 respectively under the optimized experimental conditions. The retention time of the compound was observed to be 0.595 min. The developed method was proved to be precise and accurate by calculating percent of relative standard deviation (% RSD is equal to 0.900%) for six replicate injections and mean recovery (99.8%) of famotidine at three different concentration levels. Linearity between peak area and concentration was found to be 5.0–20.0 μg/mL. The limit of detection (LOD) and limit of quantitation (LOQ) values were found to be 0.006 μg/mL and 0.02 μg/mL respectively. The drug was found to be stable (81.37%–93.44%) under different degradation conditions like acid (0.1 N HCl), alkali (0.1 N NaOH), peroxide (3% H₂O₂), photolytic and thermal.

Conclusions

The developed method was found to be simple, rapid, repeatable, reproducible, robust, rugged and economic hence it can be used as a new analytical method for the analysis of pharmaceutical formulations in any pharmaceutical industries.