Perindopril arginine and Indapamide hemihydrate in combination were proven to have\na synergistic antihypertensive impact when compared with the use of each component alone.\nTherefore, a new Ultra-High Performance Liquid Chromatography coupled with Ultraviolet\ndetector (UHPLC-UV) method has been developed and subsequently validated for simultaneous\ndetermination of the anti-hypertensive combination of Perindopril arginine and Indapamide\nhemihydrate. The separation of Perindopril arginine and Indapamide hemihydrate was achieved\nusing a BEH C18 (1.7 Ã?¼m, 2.1 Ã?â?? 50 mm) analytical column (WatersÃ?® Acquity UPLC) and a mobile\nphase composed of 0.01% v/v formic acid in water adjusted to pH 4 with acetic acid and acetonitrile\n(40:60 v/v). The method was able to separate Perindopril arginine and Indapamide hemihydrate\nwithin less than 4.5 min with high accuracy, precision, resolution, and sensitivity. The content\nof Perindopril arginine and Indapamide hemihydrate present in the dosage form Coversyl PlusÃ?®\n(5000 Ã?¼g of Perindopril arginine/1250 Ã?¼g of Indapamide hemihydrate) was determined in triplicate\nto give a concentration of 4991 Ã?¼g and 1247 Ã?¼g, respectively, from the manufacturerââ?¬â?¢s stated amounts\nwith Relative Standard Deviation (%RSD) of Ã?±0.63% for Perindopril arginine and Ã?±0.84% for\nIndapamide hemihydrate. Moreover, the degradation products of the combination were elucidated\nby UHPLC-Quadrupole Time of Flight-Mass spectrometry (UHPLC-QToF-MS) under acidic, basic,\nand thermal conditions. In conclusion, the developed UHPLC-UV method was sensitive, rapid,\nand precise. Furthermore, forced degradation studies were performed and the degradants were\nidentified by UHPLC-Electro-Spray Ionization-QToF (UHPLC-ESI-QToF).
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