International Scholarly Research Notices / 2013 / Article / Tab 6 / Research Article
Quality by Design Approach for the Development and Validation of Glipizide, an Antidiabetic Drug, by RP-UPLC with Application to Formulated Forms and Urine Table 6 Results of method robustness and ruggedness study.
Condition Modification Mean peak area ± SD % RSD Mean Rt ± SD % RSD Theoretical plates ± SD % RSD Tailing factor ± SD % RSD Actual — 2351828 ± 11571 0.49 2.130 ± 0.005 0.24 2968 ± 5.16 0.17 1.01 ± 0.005 0.47 Temperature 24°C 2346161 ± 14060 0.60 2.131 ± 0.004 0.19 2962 ± 20.00 0.68 1.10 ± 0.008 0.76 26°C 2345161 ± 16987 0.72 2.131 ± 0.004 0.20 2963 ± 16.02 0.54 1.10 ± 0.01 0.50 Mobile phase composition (acetonitrile : buffer) 35 : 65 2350328 ± 13836 0.59 2.129 ± 0.005 0.24 2960 ± 24.01 0.81 1.11 ± 0.005 0.47 45 : 55 2351828 ± 11572 0.49 2.131 ± 0.004 0.19 2970 ± 4.08 0.14 1.10 ± 0.004 0.370 Flow rate 0.22 mL/min 2346828 ± 14139 0.60 2.133 ± 0.005 0.25 2965 ± 12.11 0.41 1.14 ± 0.008 0.72 0.18 mL/min 2343495 ± 15290 0.65 2.132 ± 0.006 0.26 2968 ± 4.90 0.17 1.11 ± 0.006 0.57 Wavelength 219 nm 2348495 ± 13198 0.56 2.132 ± 0.005 0.24 2970 ± 4.00 0.13 1.10 ± 0.006 0.57 221 nm 2351802 ± 11535 0.49 2.129 ± 0.005 0.23 2960 ± 24.42 0.82 1.10 ± 0.004 0.37 Analyst 1, column 1, day 1 2350541 ± 11350 0.48 2.129 ± 0.005 0.23 2961 ± 14.95 0.50 1.11 ± 0.008 0.76 Analyst, column, day Analyst 2, column 2, day 2 2349495 ± 10475 0.45 2.129 ± 0.005 0.24 2964 ± 15.23 0.51 1.10 ± 0.005 0.47 Analyst 3, column 3, day 3 2353178 ± 12027 0.51 2.135 ± 0.010 0.47 2968 ± 6.98 0.24 1.11 ± 0.010 0.99