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

Table 1 System suitability parameters by the proposed UPLC method

Parameters	ERS1	EMPA	ERS2	ERS3	IS	Recommended value^a
Retention time	0.511	0.606	0.68	0.849	1.040	–
− k′	1.55	2.12	2.49	3.26	4.39	1–10 acceptable
α	–	1.37	1.17	1.31	1.76	> 1
R_s	–	2.15	2.01	5.51	7.81	> 2
T	0.95	1.01	1.05	0.98	1.3	≤ 2 T = 1 for a typical symmetric peak
N	12,890	3920	4023	13,205	4527	2000–10,000 increases with efficiency of the separation

^aValues defined by FDA Center of Drug Evaluation and Research’s reviewer guidance on validation of chromatographic methods [25]

ISSN: 2661-801X