And two.00 /mL). The calibration curves have been plotted between the responses of
And two.00 /mL). The calibration curves have been plotted between the responses from the peaks versus the analyte concentrations. The correlation coefficient obtained was higher than 0.998 (Table three). The above outcome shows that a great correlation existed involving the peak area and also the concentration of Imp-1, Imp-2, Imp-3, Imp-4, Imp-5, Imp-6, and Imp-7.Sci Pharm. 2013; 81: 697N. Kumar and D. Sangeetha:Tab. three.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 67617.6 59805.four 58174.two 43992.five 49474.1 123519.4 160103.1 Bias at one hundred 0.two 1.three 0.4 1.5 0.9 1.8 0.9 response Precision 1.two 2.4 3.6 1.1 0.six 1.eight 2.3 ( RSD) Intermediate precision 2.0 four.1 three.1 3.4 two.1 1.3 1.6 ( RSD) Precision at three.1 5.0 six.0 3.9 4.2 3.9 two.eight LOQ ( RSD)Accuracy To identify the accuracy on the system, recovery experiments have been conducted on the real sample by spiking the impurity blend solution. The study was carried out in triplicate making use of 4 concentration levels in the LOQ, 0.50, 1.00, and 1.50 /mL. The percentage recovery of impurities within the IL-2 MedChemExpress Rabeprazole sample varied from 92.0 to 109.1 . The LC chromatogram of your spiked sample at the 0.2 level for all seven impurities inside the rabeprazole sodium tablet sample is shown in Figure 8. The mean recovery value of every single impurity was obtained in the array of 92.009.1 which proves that the system is accurate. The recovery values for the rabeprazole impurities are presented in Table 4.Fig. eight.Typical chromatogram of Rabeprazole sodium sample spiked with its seven impuritiesSci Pharm. 2013; 81: 697Development and Validation of a Stability-Indicating RP-HPLC Strategy for the Determination …Tab. 4.Evaluation of accuracy study Imp-1 94.two three.6 96.0 1.six 96.8 1.1 92.0 1.7 Imp-2 99.1 2.6 109.1 3.three 94.1 3.0 94.6 1.three Recovery b Imp-3 Imp-4 Imp-5 95.7 104.8 104.7 three.5 0.4 2.7 95.5 93.two 106.1 3.9 two.7 1.9 98.9 93.eight 95.eight 2.9 3.three 1.9 93.eight 94.0 103.three 3.1 2.8 0.2 Imp-6 Imp-7 105.4 96.five 2.0 3.1 95.two 103.2 3.2 1.3 99.1 101.8 1.9 1.1 101.2 98.five 1.9 2.Spiked Levela LOQ 50 one hundred 150a bAmount of seven impurities spiked with respect to 0.two specification level individually; Mean RSD for three determinations.Robustness To decide the robustness from the developed approach, experimental circumstances were deliberately MEK2 Gene ID altered and also the resolution between rabeprazole and Imp-3, and system suitability parameters for the rabeprazole sodium normal have been recorded. The variables evaluated inside the study had been the pH of your mobile phase buffer (0.2), column temperature (five ), flow rate (0.2 mL/min), and organic in the mobile phase (10 ). In all of the deliberately varied chromatographic circumstances, all analytes had been adequately resolved plus the elution order remained unchanged. The resolution among the essential pair of rabeprazole and Imp-3 was higher than two.0 plus the tailing aspect for the rabeprazole peak from regular resolution was significantly less than 1.0 plus the rabeprazole peak region ratio was within 0.9 to 1.1 (Table five). Tab. five. Robustness final results of HPLC strategy Observed system suitability parameters Standard location ratio USP Tailing Resolution a 0.9 and 1.1 two.0 1.five 1.0 1.0 four.3 1.0 1.0 three.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 4.4 3.1 three.6 3.6 4.four 4.Variation in chromatographic situation Colu.