Development and Validation of Stability-Indicating RP-UPLC Method for the Determination of Methdilazine in Bulk Drug and in Pharmaceutical Dosage Form

Table 6

Method robustness.

Condition	Modification	Mean peak area ± SD*	RSD, %	Mean 𝑅𝑡  ± SD*	RSD, %	Mean theoretical plates ± SD*	RSD, %	Mean tailing factor ± SD*	RSD, %
Temperature	30°C	2997425±3368	0.11	2.226±0.005	0.21	2702±59.65	2.20	1.25±0.01	0.80
	35°C	2932419±6736	0.22	2.224±0.003	0.14	2767±39.36	1.42	1.23±0.02	1.62
	40°C	2947846±5823	0.19	2.222±0.004	0.18	2786±47.56	1.70	1.28±0.02	1.56
Mobile phase composition	65 : 35	2943821±5638	0.19	2.220±0.006	0.26	2689±53.36	1.98	1.32±0.02	1.62
	60 : 40	2891630±4178	0.14	2.221±0.005	0.24	2772±32.56	1.17	1.27±0.02	1.57
	55 : 45	2985915±6281	0.21	2.216±0.005	0.25	2865±55.97	1.95	1.35±0.01	0.74
Flow rate, min	0.20	2915998±5246	0.18	2.224±0.005	0.21	2805±48.16	1.71	1.29±0.02	1.55
	0.25	2908856±2857	0.10	2.219±0.004	0.18	2698±42.84	1.58	1.30±0.01	0.76
	0.30	2991556±6649	0.22	2.221±0.003	0.14	2791±53.16	1.90	1.22±0.02	1.63
Wavelength	253 nm	2906684±4479	0.15	2.228±0.008	0.35	2695±35.16	1.30	1.34±0.02	1.49
	254 nm	3042479±3805	0.09	2.215±0.006	0.27	2747±42.3	1.53	1.32±0.02	1.51
	255 nm	2944213±8138	0.28	2.224±0.004	0.17	2698±38.58	1.42	1.28±0.02	1.96

*Mean value of three determinations.