S validated as per ICH recommendations [17, 18]. The following validation characteristics had been addressed: specificity, accuracy, precision, limit of detection and quantification, linearity, variety, and robustness. Technique Suitability Program suitability was determined prior to sample analysis from a single injection of system suitability solution and duplicate injections from the typical option containing 1.6 /mL rabeprazole sodium. The acceptance criteria had been a USP tailing factor significantly less than 2.0 and an area similarity ratio in between 0.9 to 1.1 for the rabeprazole peak from duplicate injections of the normal and from the program suitability remedy, where resolution should be a minimum of 1.five in between rabeprazole and Imp-3 peaks. All critical parameters tested met the acceptance criteria (Table 1). Tab. 1. Method suitability test final results Parameters Resolutiona Regular area ratio USP TailingaSpecification 1.5 0.9 and 1.1 two.Observed values Intermediate Precision Precision 4.two four.2 1.0 1.0 1.0 1.Resolution involving Rabeprazole and Imp-3.Sci Pharm. 2013; 81: 697?Development and Validation of a Stability-Indicating RP-HPLC Process for the Determination …Specificity Specificity is the capacity from the technique to measure the analyte response in the presence of its possible impurities and excipients. Placebo interference was evaluated by analyzing the placebo Caspase 10 Activator Biological Activity prepared as per test process. There was no interference due to the placebo and sample diluent in the retention time of rabeprazole and its impurities (Figure two).Fig. two.Typical chromatogram of the placebo.Forced Degradation Studies Forced degradation research have been performed at a 500 /mL concentration of rabeprazole sodium in Caspase 2 Activator Synonyms tablet kind to provide an indication of the stability-indicating home and specificity of your proposed technique. All forced degradation samples have been analyzed using a PDA detector to make sure the homogeneity and purity with the rabeprazole peak. All recognized impurities and unknown degradation items had been well-separated below all the forced degradation conditions employed, and the purity angle was discovered to become less than the purity threshold for the rabeprazole peak. Apart from the peaks’ homogeneity, the PDA spectrum for all of the associated impurities and rabeprazole had been compared against their normal spectrums. Identification of your impurities and rabeprazole was performed by comparing their PDA spectrums, purity plots, and their relative retention times (RRT) along with these in the normal and have been discovered to be matching. The mass balance ( assay + sum of all degradants + sum of all impurities) final results have been calculated for all degradation samples and discovered to become a lot more than 97.3 (Table two). All the solutions utilised in the forced degradation research were prepared by dissolving the drug solution inside a modest volume of stressing agents. Right after degradation, these options have been diluted with diluent to yield the stated rabeprazole sodium concentration of about 500 /mL. Conditions employed for performing the anxiety studies plus the degradation behavior have been as follows [16?8]: Acid Degradation Tablet powder equivalent to 25 mg of rabeprazole sodium was transferred into a 50 mL volumetric flask, then 10 mL of diluent and 3 mL of 0.1 M HCl have been added and mixed to dissolve the content absolutely. The flask was placed at 60 in a water bath for 45 min. Right after 45 min, the flask was removed and placed on the benchtop to attain the laboratory temperature. To neutralize the sample, three mL of 0.1 M NaOH wa.