DETERMINATION OF RESIDUAL CHLORIDE IN SEVELAMER CARBONATE USING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

What is it about?

Sevelamer carbonate is manufactured from sevelamer hydrochloride, in which carbonate replaces chloride as the counter ion. Therefore, chloride is one of the impurities present in sevelamer carbonate. This paper describes determination of the residual chloride in sevelamer carbonate API using an isocratic HPLC method with refractive index detector. The proposed HPLC method provides equal sensitivity with ion chromatography.

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Photo by National Cancer Institute on Unsplash

Photo by National Cancer Institute on Unsplash

Why is it important?

A number of suitable analytical techniques are available for chloride estimation, including titration, colorimetry, electrochemical chromatography, indirect photochemical detection, and ion chromatography. Limits of detection range from 50 g=L for colorimetry to 5 mg=L for titration. The speci- fication limit of chloride content in sevelamer carbonate is not more than 0.05%. As a result, accurate determination of this residual chloride in sevelamer carbonate is not possible with colorimetry and titration. In the case of electrochemical detectors, the electrode response could drift with time. Indirect photometric detection is a more time consuming method. A novel isocratic reverse phase HPLC method has been developed in order to detect and quantify the residual chloride.