Identification and Determination of Impurities in a New Therapeutic Agent for Fatty Liver Disease

Table 2

Summary of the validation report of the proposed methods.

Parameters	I	II	III	IV	V
Linear equation	y = 1.7418x − 0.0134	y = 2.6599x − 0.0328	y = 2.5719x − 0.0266	y = 1.7827x − 0.0168	y = 165113x − 26088
R	0.9999	0.9999	0.9998	0.9999	0.9999
Linearity range (μg/mL)	0.10–2.03	0.10–2.03	0.10–2.03	0.10–2.03	0.34–27.31 ng/mL
LOD (μg/mL)	0.005	0.005	0.005	0.005	0.05 ng/mL
LOQ (μg/mL)	0.01	0.01	0.01	0.01	0.17 ng/mL
Precision (%) (n = 6)	0.75	1.08	0.42	1.05	0.36
Repeatability (%) (n = 6)	3.65	3.36	2.25	5.22	8.72
Stability (%)	2.10	4.04	1.53	2.55	0.57
Accuracy at low level (n = 3)
Recovery (%)	102.99	101.96	104.80	100.98	91.18
RSD (%)	3.09	3.09	3.64	2.30	1.89
Accuracy at medium level (n = 3)
Recovery (%)	102.68	98.35	104.20	101.69	111.27
RSD (%)	3.69	0.70	1.83	1.78	0.58
Accuracy at high level (n = 3)
Recovery (%)	102.53	100.84	105.78	103.28	102.96
RSD (%)	2.28	1.89	1.93	1.83	0.73