Biological Safety Studies and Simultaneous Determination of Linagliptin and Synthetic Impurities by LC-PDA

Table 4

Parameters evaluated and responses obtained on the robustness of LGT and synthetic impurities.

	Parameters
	pH	Mobile phase	T (°C)	Flow rate	λ
LGT (%)	100.0	100.0	100.0	99.8	99.9
IMP 1 (%)	100.0	100.0	99.9	99.8	99.9
IMP 2 (%)	100.3	100.0	100.3	100.7	99.7
IMP 3 (%)	100.5	100.0	100.2	100.2	100.0

LGT: linagliptin; IMP 1: impurity 1; IMP 2: impurity 2; IMP 3: impurity 3; MP: mobile phase; T (°C): temperature; λ: wavelength.