A UPLC/DAD method for simultaneous determination of empagliflozin and three related substances in spiked human plasma

Table 2 Validation parameters of the proposed UPLC method for the determination of EMPA and its three related substances in spiked human plasma

Parameter	EMPA in spiked human plasma	ERS1	ERS2	ERS3
Range (ng/mL)	50–700	40–200	40–200	40–200
n	8	5	5	5
LOD (ng/mL)^a	15	11.5	12	12.5
LLOQ (ng/mL)^b	50	40	40	40
Accuracy
Intra-day^c	97.09	97.86	99.28	96.97
Inter-day^d	98.18	99.47	98.20	99.67
Precision ± %RSD
Intra-day^c	± 6.38	± 7.26	± 7.94	± 7.34
Inter-day^d	± 6.63	± 7.93	± 6.60	± 7.42
Linearity
Slope	0.0003	0.0002	0.0005	0.0007
Standard deviation of slope	5.7 × 10⁻⁶	5.8 × 10⁻⁶	7.6 × 10⁻⁶	6.8 × 10⁻⁶
Intercept	− 0.0016	− 0.0008	− 0.0004	− 0.0032
Standard deviation of intercept	0.00001	0.00002	0.00001	0.00007
Correlation coefficient (r)	0.9999	0.9994	0.9999	0.9997

^aLOD is the lowest detectable amount of the selected drug that could be detected
^bLLOQ is the lowest concentration of the analyte that can be measured accurately under the proposed experimental condition
^cThe intra-day study was performed for five concentrations for EMPA and its related substances (ERS 1–3), repeated three times within the day
^dThe inter-day study was performed for five concentrations for EMPA and its related substance (ERS 1–3), repeated three times in 3 successive days

ISSN: 2661-801X