Method development and validation of ifetroban and droxidopa by sophisticated analytical techniques

Abstract

Stability indicating High performance liquid chromatography HPLC method involves the prediction of likely impurities within the synthetic process their isolation and identification by suitable analytical techniques The hyphenated techniques such as GCMS and LCMS are widely used for characterization of complex mixtures determination of molecular weights molecular structure UPLC enables high resolution resulting in significant advantages in analytical performance over traditional HPLC UPLC can provide up to 20 times faster analysis and higher resolution than conventional Highperformance liquid chromatography HPLC After a thorough literature survey stability indicating method was developed for Ifetroban and Droxidopa followed by validation of the developed method as per ICH guidelines LCMS method was developed and degradation studies under various stress conditions like acidic basic oxidative thermal and photolytic conditions were carried out UPLC method has been successfully developed and validated for pharmaceutical analysis of Ifetroban and Droxidopa In HPLC method pharmaceutical additives and degradation products did not intrude with the peak of the Ifetroban or Droxidopa Method was validated and found to be precise specific robust and can separate all the potential impurities and degradants from each other purity threshold was greater than the purity angle which proves stability indicating method From the mz of the degradation products obtained by LCMS method developed for Ifetroban and Droxidopa degradation pathways were proposed The chromatographic separations of Ifetroban and Droxidopa were achieved with shorter run time by UPLC when compared to HPLC newline