The Development and Validation of a Stability-Indicating UHPLC-DAD Method for Determination of Perindopril l-Arginine in Bulk Substance and Pharmaceutical Dosage Form.
A stability-indicating ultra-high-performance liquid chromatography (UHPLC) method with a diode array detector was developed and validated for the determination ofcis/transisomers of perindopril l-arginine in bulk substance and pharmaceutical dosage form. The separation was achieved on a Poroshell 120 Hilic (4.6 × 150 mm, 2.7 µm) column using a mobile phase composed of acetonitrile-0.1 % formic acid (20:80v/v) at a flow rate of 1 mL min-1. The injection volume was 5.0 µL and the wavelength of detection was controlled at 230 nm. The selectivity of the UHPLC-DAD method was confirmed by determining perindopril l-arginine in the presence of degradation products formed during acid-base hydrolysis and oxidation as well as degradation in the solid state, at an increased relative air humidity and in dry air. The method's linearity was investigated in the ranges 0.40-1.40 µg mL-1for isomer I and 0.40-2.40 µg mL-1for isomer II of perindopril l-arginine. The UHPLC-DAD method met the precision and accuracy criteria for the determination of the isomers of perindopril l-arginine. The limits of detection and quantitation were 0.1503 and 0.4555 µg mL-1for isomer I and 0.0356 and 0.1078 µg mL-1for isomer II, respectively.
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznan, Poland.
Magdalena
M
Paczkowska
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznan, Poland.
Przemysław
P
Zalewski
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznan, Poland.
Piotr
P
Garbacki
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznan, Poland.
Alicja
A
Talaczyńska
PozLab sp.z.o.o, Poznan, Poland.
Anna
A
Krause
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznan, Poland.
Judyta
J
Cielecka-Piontek
Perindopril; Stability; UHPLC-DAD; cis–trans isomers