Implementation of Quality by Design for the Development and Validation of Pioglitazone Hydrochloride by RP-UPLC with Application to Formulated Forms

Table 7

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	—	504198 ± 4130	0.82	2.212 ± 0.001	0.05	3325 ± 8.25	0.25	1.05 ± 0.004	0.39
Temperature	24°C	505867 ± 5852	1.16	2.212 ± 0.001	0.03	3318 ± 6.08	0.18	1.05 ± 0.008	0.78
	26°C	505799 ± 5915	1.17	2.207 ± 0.010	0.45	3435 ± 25.24	0.73	1.05 ± 0.01	1.00
Mobile phase composition; (acetonitrile : buffer)	15 : 85	522201 ± 521	0.10	2.213 ± 0.002	0.09	3327 ± 10.12	0.30	1.06 ± 0.006	0.55
	25 : 75	506001 ± 5735	1.13	2.212 ± 0.002	0.09	3329 ± 23.46	0.70	1.05 ± 0.008	0.80
Flow rate	0.22 mL/min	505834 ± 5880	1.16	2.215 ± 0.006	0.27	3331 ± 27.02	0.81	1.05 ± 0.008	0.78
	0.18 mL/min	502734 ± 2170	0.43	2.211 ± 0.001	0.05	3325 ± 15.18	0.46	1.04 ± 0.010	0.92
Wavelength	219 nm	502267 ± 799	0.16	2.211 ± 0.001	0.05	3335 ± 11.93	0.36	1.04 ± 0.009	0.86
	221 nm	502334 ± 521	0.10	2.213 ± 0.003	0.15	3314 ± 5.77	0.17	1.05 ± 0.006	0.55
	Analyst-1, column-1, day-1	504198 ± 4130	0.82	2.212 ± 0.001	0.05	3325 ± 8.25	0.25	1.05 ± 0.004	0.39
Analyst, column, day	Analyst-2, column-2, day-2	502634 ± 295	0.06	2.214 ± 0.004	0.17	3335 ± 31.94	0.96	1.05 ± 0.010	1.09
	Analyst-3, column-3, day-3	505967 ± 5764	1.14	2.214 ± 0.003	0.13	3320 ± 9.02	0.27	1.05 ± 0.010	0.80