A VALIDATED HPLC METHOD FOR DETERMINATION OF RESIDUAL FORMIC ACID IN DRUG SUBSTANCES

摘要

Formic acid and formaldehyde if present in traces can react with amino and hydroxyl groups in drug substances to form significant levels of degradants. For the determination of content of free formic acid in drug substances and their intermediates, a reverse phase high performance liquid chromatography (RP-HPLC) method with gradient elution has been developed and validated. C-18 RP-HPLC column is used with UV-Vis detection at 220 nm. Mobile phase consisted of 0.01 M of monobasic potassium phosphate with 1.0 ml_ of ortho phosphoric acid per litre and acetonitrile. The method is validated for its specificity, precision, accuracy, linearity and ruggedness. Response of formic acid is linear from 0.75mcg/mL to 37.65 mcg/mL Limit of quantitation of the method is 0.753 mcg/mL and limit of detection is 0.502 mcg/mL.