[Ion pair-HPLC of a pharmaceutical multicomponent system].

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Context:

• Aminophyllin compositum tablets contain a mixture of non-ionic (methyl- and propylhydroxybenzoate) and ionic (theophylline, phenobarbital, atropine methobromide, demelverine hydrochloride) analytes.
• These analytes are therapeutically used as effective bronchodilators.

Purpose:

• To investigate and optimize an ion-pair High-Performance Liquid Chromatography (HPLC) technique for the simultaneous analysis of a multicomponent system of non-ionic and ionic analytes.
• To evaluate the effectiveness of different ion-interaction reagents (IIR), including alkylsulfonates and sodium cyclamate, for separating these compounds on reversed-phase columns.
• To study the influence of various factors on analyte retention and explore the use of 'mixed' IIR for enhanced separation.

Summary:

• An ion-pair HPLC method was developed and applied to a complex mixture of non-ionic and ionic compounds found in bronchodilator formulations.
• The study systematically investigated the use of alkylsulfonates and sodium cyclamate as ion-interaction reagents (IIR), detailing their impact on chromatographic retention.
• The research explored the potential of employing 'mixed' IIR strategies to achieve improved separation of the analytes, demonstrating a practical approach to pharmaceutical analysis.

Impact:

• Provides an optimized analytical method for the quality control of multicomponent bronchodilator medications.
• Offers insights into the selection and application of ion-interaction reagents for complex pharmaceutical separations using HPLC.
• Contributes to the advancement of analytical techniques for the precise determination of both ionic and non-ionic active pharmaceutical ingredients in drug products.