title: Evaluation of impurities level of perindopril tert-butylamine in tablets.
abstract: Perindopril tert-butylamine is a new member of angiotensin-converting enzyme inhibitors group used in the treatment of hypertension and heart failure. In this paper, the evaluation of reversed-phase high-performance liquid chromatographic method (RP-HPLC) for the determination of impurities level of perindopril tert-butylamine in tablets was done. The chromatograms were recorded using a Hewlett Packard 1100 chromatographic system with DAD detector. Separations were performed on a YMC-Pack C8 column (250 mm x 4.6mm; 5 microm particle size) at 50 degrees C column temperature. Mobile phase was a mixture of acetonitrile-potassium phosphate buffer (0.05 M) (37:63, v/v) (pH 2.5). pH of the mobile phase was adjusted with ortophosphoric acid. Mixture of acetonitrile-water (40:60, v/v) was used as a solvent. Injection volume was 50 microl, flow rate 1.7 ml min(-1) and UV-detection was performed at 215 nm. The developed method subjected to method validation and parameters in terms of selectivity, linearity, precision, accuracy, limit of detection, limit of quantitation and robustness were defined. The validated method is suitable for the simultaneous determination of perindopril tert-butylamine as well as its impurities in pharmaceuticals.
authors.affiliation: Faculty of Pharmacy, Department of Physical Chemistry, Vojvode Stepe 450, 11000 Belgrade, Serbia. medenica@pharmacy.bg.ac.yu
authors.forename: M
authors.initials: M
authors.lastname: Medenica
authors.forename: D
authors.initials: D
authors.lastname: Ivanović
authors.forename: M
authors.initials: M
authors.lastname: Masković
authors.forename: B
authors.initials: B
authors.lastname: Jancić
authors.forename: A
authors.initials: A
authors.lastname: Malenović
mesh_terms: D000097:Acetonitriles / Q000737:chemistry; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000032:analysis* / Q000737:chemistry; D002021:Buffers; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004340:Drug Contamination / Q000517:prevention & control; D006863:Hydrogen-Ion Concentration; D015394:Molecular Structure; D020913:Perindopril / Q000032:analysis* / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry; D010710:Phosphates / Q000737:chemistry; D017680:Potassium Compounds / Q000737:chemistry; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012996:Solutions / Q000737:chemistry; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D013696:Temperature
chemical_list: D000097:Acetonitriles; D000806:Angiotensin-Converting Enzyme Inhibitors; D002021:Buffers; D004364:Pharmaceutical Preparations; D010710:Phosphates; D017680:Potassium Compounds; D012996:Solutions; D013607:Tablets; C013216:potassium phosphate; D020913:Perindopril; C032159:acetonitrile