HPLC-DAD technique for the quantification of a recently approved anti-diabetic triple combination along with two toxic official impurities: Toxicity confirmation aided by molecular docking application

Table 1 Results obtained by applying the current HPLC method for the determination of EMP, LIN, and MET along with MEL and CYG as MET potential official impurities in Trijardy XR^® tablets and application of standard addition technique

Pharmaceutical preparation								Current HPLC method
Pharmaceutical preparation								EMP		LIN		MET
Trijardy ^® tablets, (25 mg EMP/5 mg LIN/1000 mg MET per tablet)							Mean ± SD	101.20 ± 0.355		99.08 ± 1.272		99.59 ± 0.671
Standard addition technique
Current HPLC method
Pharmaceutical formulation taken ( µg/mL)			Pure drug added (µg/mL)			% Recovery ^a of EMP			% Recovery ^a of LIN		% Recovery ^a of MET
EMP	LIN	MET	EMP	LIN	MET	% Recovery ^a of EMP			% Recovery ^a of LIN		% Recovery ^a of MET
2.5	0.5	100	2.00	0.40	80.00	101.02			99.82		99.72
			2.50	0.50	100.00	100.47			101.61		101.11
			3.00	0.60	120.00	99.76			100.52		101.58
Mean ± SD						100.42 ± 0.630			99.08 ± 1.272		99.59 ± 0.671

^a Mean of three determinations
MET, metformin; MEL, melamine; CYG, cyanoguanidine; LIN, linagliptin; EMP, empagliflozin

ISSN: 2661-801X