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