Improved USP Monograph Assay Time for Drug Products Used to Treat Tuberculosis

This new application from Dionex, AN 257: HPLC Assay Method for Drug Products Containing Anti-Tuberculosis Active Pharmaceutical Ingredients, uses the hydrolytic-stability-enhanced Acclaim® PolarAdvantage II (PA2) column with an UltiMate® 3000 system to assay drug products using either a conventional HPLC approach or a time- and mobile-phase saving UHPLC approach. All APIs can be determined with one method rather than two, and in less time.

The two HPLC assay methods previously described in the USP monograph require two separate injections and use different mobile phases, requiring equilibration between tests. In comparison, this new single-injection method can determine all four anti-tuberculosis APIs commonly used to treat TB (isoniazid, pyrazinamide, rifampicin, and ethambutolare) in 10 minutes. The analysis of two representative drug products yielded acceptable percentage contents, as judged by the limits in the USP monograph. Further savings and waste reduction are possible with the UHPLC method that requires less than 2 minutes per injection.