Determination of sulfate and glutarate ions in Abac avir Hemisulfate using ion chromatography with conductivity detectio n


Abstract 



A simple and accurate ion chromato-graphic method was developed for the determination of sulfate content in presence of glutaric acid in (1S, 4R)-4- [2- amino-6-(cyclopropyl amino)-9H-purin-9-yl]-2-cyclopentene- 1-methanol hemisulfate, commercially known as Abacavir hemisulfate drug substance. In the titration method for sulfate content using alkaline solution, there is a high probability of interference of glutaric acid present at trace levels. Chromatographic separation between sulfate anion and glutarate anion has been achieved on Metro sep A supp-5 Ion exchange column using a mobile phase system containing a mixture of 1.0 mM sodium hydrogen carbonate, 6.0 mM sodium carbonate prepared in HPLC grade water, mixed with Acetonitrile in the ratio of 7:3 (v/v). The resolution between the two anions was found to be more than 5. The limit of detection (LOD) and limit of quantification (LOQ) of glutarate anion was 16 and 50 ng.mL-1respectively, for 20 μ L injection volume. The percentage recovery of sulfate ranged from 99 to 102 % w/win the (1S, 4R)-4- [2- amino- 6- (cyclopropyl amino) - 9 H- purin- 9-yl]-2- cyclopentene- 1-methanol hemisulfate sample. 

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