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Acta Pol Pharm ; 73(6): 1475-1485, 2016 Nov.
Article in English | MEDLINE | ID: mdl-29634101

ABSTRACT

The chromatographic behavior of some basic and acidic drugs was studied on Cl 8, Phenyl-Hexyl and Polar RP columns with methanol or acetonitrile as organic modifiers of aqueous mobile phases containing addition of diethylamine. Diethylamine plays a double function of silanol blocker reagent in analysis of basic drugs and ion-pair reagent in analysis of acidic drugs. Most symmetrical peaks and highest system efficiency were obtained on Phenyl-Hexyl and Polar RP columns in tested mobile phase systems compared to results obtained on C18 column. A new rapid, simple, specific and accurate reverse phase liquid chromatographic method was developed for the simultaneous determination of atorvastatin - antihyperlipidemic drug and amlodipine - calcium channel blocker in one pharmaceutical formulation. Atorvastatin is an acidic compounds while amlodipine is a basic substance. The chromatographic separation was carried out on Phenyl-Hexyl column by gradient elution mode with acetonitrile as organic modifier, acetate buffer at pH 3.5 and Q.025 M/L diethylamine. The proposed method was validated for specificity, precision, accuracy, linearity, and robustness. The linearity range of atorvastatin and amlodipine for 5 - 100 µg/mL was obtained with limits of-detection (LOD) 3.2750 gg/mL and 3.2102 µg/mL, respectively. The proposed method made use of DAD as a tool for peak identity and purity confirmation.


Subject(s)
Amlodipine/analysis , Chromatography, High Pressure Liquid/methods , Chromatography, Reverse-Phase/methods , Heptanoic Acids/analysis , Pyrroles/analysis , Amlodipine/chemistry , Anticholesteremic Agents/analysis , Anticholesteremic Agents/chemistry , Antihypertensive Agents/analysis , Antihypertensive Agents/chemistry , Diethylamines/chemistry , Drug Combinations , Heptanoic Acids/chemistry , Hydrogen-Ion Concentration , Limit of Detection , Pyrroles/chemistry , Reproducibility of Results , Sensitivity and Specificity
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