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SIMULTANEOUS CHIRAL SEPARATION OF PERINDOPRIL ERBUMINE AND INDAPAMIDE ENANTIOMERS BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

ANCA GABRIELA CÂRJE ¹, GABRIEL HANCU ^2*, DANIELA-LUCIA MUNTEAN ¹, ALINA BALINT ¹, VALENTIN ION ¹, SILVIA IMRE ¹

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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.