Simultaneous Determination of Tartaric Acid and Tolterodine in Tolterodine Tartrate

5 Mar 2013

This application note demonstrates an accurate and reproducible HPLC method for the single-injection determination of tolterodine and tartrate - the API and its counterion - in an encapsulated drug product containing tolterodine tartrate.

Thermo Scientific™ Acclaim™ Trinity P1 LC Column

Thermo Fisher Scientific

Acclaim™ Trinity P1 is a unique, high-efficiency, silica-based column designed for pharmaceutical applications such as simultaneous separation of pharmaceutical drug substances and their counterions. his new column, based on nanopolymer silica hybrid (NSH) technology, provides multiple retention mechanisms including reversed-phase, anion-exchange, and cation-exchange. As a result, its selectivity can be easily optimized by adjusting mobile phase buffer concentration, pH, and solvent content concurrently or independently.The NSH technology ensures distinctive spatial separation of the anion-exchange and cation-exchange regions, which results in maximum flexibility in method development. The easy-to-optimize selectivity can be used to accelerate chromatographic separations and increase productivity.Acclaim Trinity P1 LC Column Features: Multiple retention mechanisms including reversed-phase, anion-exchange, and cation-exchange Adjustable selectivity by mobile phase ionic strength, electrolyte type, pH and organic solvent Ideal selectivity for simultaneous separation of basic, neutral, and acidic analytes Separation of hydrophilic ionic and ionizable analytes without ion-pairing reagents Applications: Active Pharmaceutical Ingredients (API) and counterions (cations or anions). Screening of pharmaceutical counterions. Both UV and an ELS detector, in series, are required for simultaneous determination of both drug substances and counterions. Mixture of acidic and basic drug substances and respective counterions. Drug substances: of acidic, basic and neutral mixtures. High throughput analysis following optimization of the selectivity and resolution. The flow rate can then be increased, and the analysis time shortened. Column Details: Chemistry: SCX, WAX and RP Mixed-Mode Length: 50, 100, 150 mm ID: 2.1, 3.0 mm

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Simultaneous Determination of Tartaric Acid and Tolterodine in Tolterodine Tartrate