A validated high performance liquid chromatographic method for analysis of isosorbide mononitrate in bulk material and extended release formulations.

A reversed phase HPLC method using C(18) column was developed for the quantitative determination of isosorbide mononitrate (IMN) in the bulk material and extended release dosage forms. The method was specific to IMN and able to resolve the drug peak from the pharmacopoeial impurities and formulation excipients. The method was accurate, precise, and linear within the desired range. In addition to analysis of assay and dissolution samples, the method was successfully used for analysis of drug-excipient compatibility samples of IMN used for development of extended release formulations in our laboratory and their subsequent stability studies. The method was also used for analysis of IMN in commercially available raw material.