Two separation methods were developed for the determination of S- and R-perindopril tert-butylamine (erbumine salt) (PER): high performance liquid chromatography (HPLC) and capillary electrophoresis (CE). The HPLC method uses a chiral stationary phase (CSP), ChiraDex column constituting -cyclodextrin chemically bonded to spherical silica gel particles. The mobile phase consisted of phosphate buffer (50 mM, pH 3.0) and acetonitrile (45 : 55 v/v). The flow rate was 1.0 mL min1 and the detection wavelength was 210 nm. In CE, 2-hydroxylpropyl--cyclodextrin (10 mM) was used as a chiral selector. It was added to the background buffer composed of phosphate buffer (100 mM, pH 7.0) and methanol (15% v/v). The applied voltage was 15 kV and the detection was carried out using a diode array detector. All factors affecting the chromatographic or electrophoretic separations were studied and optimized. The linear concentrations ranged from 5–150 and 25–800 µg mL1 with detection limits of 2.3 and 14.7 µg mL1 for HPLC and CE methods, respectively. The methods were validated according to ICH and USP guidelines. The suggested methods were applied for the determination of S-PER in bulk powder and commercial tablets containing PER erbumine racemate.
قسم البحث
مجلة البحث
Anal. Methods, DOI: 10.1039/c3ay42056f
تصنيف البحث
1
عدد البحث
Vol. 6
سنة البحث
2014
المشارك في البحث
ملخص البحث