高压毛细管离子色谱快速测定药物中无机反离子

前言：

One of the most important applications of ion chromatography (IC) is the determination of counterions in active pharmaceutical ingredients (APIs) and in drug products in pharmaceutical industry.1 Approximately 50% of drugs on the market are developed in salt forms.2,3 Certain physicochemical and biopharmaceutical properties of APIs can be improved by pairing a basic or acidic drug molecu le with a counterion to create a salt version of the drug with high solubility, stable crystalline form, and good bioavailability. Ion chromatography with suppressed conductivity detection plays an important role in the salt selection process to establish correct molecular mass of the entity in early stages of drug development. IC can also be used in quality control to verify identity, strength, and purity of ionic APIs.

This application brief describes the determination of counter anion chloride in a drug for type 2 diabetes treatment with the Thermo Scientific Dionex ICS-5000 Capillary HPIC system, which can operate at backpressures up to 5000 psi. This capability facilitates higher sample throughput by simply increasing the flow rate. As shown in Figure 1, the analysis of a counterion can be achieved in less than 8 min at 24 μL/min compared to 15 min at a 12 μL/min flow rate using a Thermo Scientific Dionex IonSwift MAX-100 capillary column and suppressed conductivity detection. The Dionex IonSwift™ MAX-100 column uses monolith technology and is designed for the separation of small molecules and inorganic anions using a hydroxide gradient delivered by an eluent generator. At a 24 μL/min flow rate, about 4500 psi backpressure is generated.

仪器：

Thermo Scientific Dionex ICS-5000