.Tab. 2.Summary of forced degradation results ImpurityaStress Situation Acid hydrolysis Base hydrolysis Oxidation degradation Thermal Degradation Water Degradation Photolytic degradation Humidity DegradationaI-I-I-I-I-I-I-MUSI two.06 four.61 1.07 1.63 0.27 0.03 0.ND 0.02 0.02 0.27 1.23 0.70 0.03 ND 0.02 ND 0.27 2.41 two.17 0.09 ND two.48 ND 0.02 ND ND ND ND ND ND ND ND ND ND ND three.27 0.04 0.11 NDMass Degrbalance adation ( ) 6.52 98.5 12.01 one hundred.9 eight.50 five.33 4.07 0.30 0.29 97.three 101.3 101.0 99.eight 100.0.31 0.41 0.09 0.52 0.28 0.29 2.01 0.07 0.20 0.18 ND ND ND ND ND NDMUSI = Maximum un-specified impurity; ND = Not detected.Precision The precision of your system was verified by repeatability and intermediate precision. Repeatability was checked by injecting six person preparations of rabeprazole sodium samples spiked with its seven impurities (0.2 of each impurity with respect to 500 /mL rabeprazole sodium). The intermediate precision from the technique was also evaluated using distinctive analysts and different instruments and performing the analysis on different days. The RSD for the area of Imp-1, Imp-2, Imp-3, Imp-4, Imp-5, Imp-6, and Imp-7 in the repeatability study was inside 4.7 and through the intermediate precision study was within four.1 , confirming very good precision with the system. The RSD values are presented in Table 3. Limits of Detection and Quantification The LOD and LOQ for all impurities were determined at a signal-to-noise ratio of three:1 and ten:1, respectively, by injecting a series of dilute solutions with known concentrations. The precision study was also carried out at the LOQ level by injecting six person preparations and calculating the RSD on the region for each and every analyte.L-Azidohomoalanine Cancer The limit of detection, limit of quantification, and precision in the LOQ values for all seven impurities of rabeprazole sodium are reported in Table 3.Pertussis Toxin manufacturer Linearity Linearity test options have been ready by diluting impurity stock solutions towards the expected concentrations. The solutions were ready at six concentration levels in the LOQ to 200 with the specification level (ie. LOQ, 0.25, 0.50, 1.00, 1.50, and two.00 /mL). The calibration curves have been plotted in between the responses from the peaks versus the analyte concentrations. The correlation coefficient obtained was greater than 0.998 (Table 3). The above outcome shows that a superb correlation existed involving the peak location along with the concentration of Imp-1, Imp-2, Imp-3, Imp-4, Imp-5, Imp-6, and Imp-7.PMID:24120168 Sci Pharm. 2013; 81: 697N. Kumar and D. Sangeetha:Tab. 3.Linearity and precision dataParameter Imp-1 Imp-2 Imp-3 Imp-4 Imp-5 Imp-6 Imp-7 LOD ( /mL) 0.029 0.028 0.032 0.061 0.058 0.026 0.025 LOQ ( /mL) 0.087 0.083 0.097 0.181 0.175 0.079 0.076 Correlation 0.999 0.999 0.999 0.999 0.999 0.999 0.999 coefficient Intercept 15.23 -357.57 -114.90 -962.70 1021.47 981.50 748.25 Slope 67617.six 59805.4 58174.2 43992.5 49474.1 123519.4 160103.1 Bias at one hundred 0.two 1.3 0.4 1.five 0.9 1.eight 0.9 response Precision 1.two two.four 3.6 1.1 0.six 1.eight 2.three ( RSD) Intermediate precision 2.0 4.1 3.1 3.four two.1 1.3 1.six ( RSD) Precision at 3.1 5.0 six.0 three.9 four.2 three.9 two.eight LOQ ( RSD)Accuracy To identify the accuracy on the system, recovery experiments were carried out around the real sample by spiking the impurity blend answer. The study was carried out in triplicate using 4 concentration levels at the LOQ, 0.50, 1.00, and 1.50 /mL. The percentage recovery of impurities in the rabeprazole sample varied from 92.0 to 109.1 . The LC chromatogram with the spiked sa.