SIMULTANEOUS CHIRAL SEPARATION OF PERINDOPRIL
ERBUMINE AND INDAPAMIDE ENANTIOMERS BY HIGH
PERFORMANCE LIQUID CHROMATOGRAPHY
ANCA GABRIELA CÂRJE1, GABRIEL HANCU2*, DANIELA-LUCIA MUNTEAN1, ALINA BALINT1, VALENTIN ION1, SILVIA IMRE1
1University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Analytical Chemistry and Drug Analysis, Târgu
Mureş, Romania
2University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Chemistry, Târgu Mureş, Romania
*corresponding author: gabriel.hancu@umftgm.ro
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Abstract:
Simultaneous enantioseparation of perindopril tert-butylamine (PER) and indapamide (IMP) enantiomers was developed
successfully by high performance liquid chromatography using ovomucoid as chiral selector. The chiral separation was
performed on an Agilent 1100 Series HPLC system (Agilent Technologies, USA) equipped with UV-VIS detector using an
Ultron ES OVM, 150 x 4.6 mm, 5 μm (Shinwa Chemical Industries LTD, Agilent Technologies) column. The effects of
organic modifier, the buffer pHs, the column temperature and the injection volume have been investigated considering
resolution and selectivity. The analytical results of the proposed method showed that optimal experimental conditions were: a
mobile phase consisting of 93% KH2PO4 20 mM pH 3.75 and 7% acetonitrile, under an isocratic elution (flow rate = 1
mL/min) with an injection volume of 5 μL and a temperature of 25°C in a less than 15 minutes analysis time. The method
was validated for linearity, limits of detection (LOQ) and quantification (LOD), recovery and precision of retention time and
peak-area response. The linearity of the method has been established in the range of 20 - 200 μg/mL for PER and 6.25 - 62.5
μg/mL for IMP respectively. Good results were obtained from the analysis of tablets indicating that the proposed method is
suitable for the simultaneous analysis of PER and IMP in pharmaceutical fixed-dose combinationS.

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