RP-HPLC ANALYSIS OF ACIDIC AND BASIC DRUGS IN SYSTEMS WITH DIETHYLAMINE AS ELUENTS ADDITIVE

Acta Pol Pharm. 2016 Nov;73(6):1475-1485.

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.

Publication types

  • Comparative Study
  • Validation Study

MeSH terms

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

Substances

  • Anticholesteremic Agents
  • Antihypertensive Agents
  • Diethylamines
  • Drug Combinations
  • Heptanoic Acids
  • Pyrroles
  • amlodipine, atorvastatin drug combination
  • Amlodipine
  • diethylamine