Characterization of stress degradation products of fosinopril by using LC-MS/TOF, MSn and on-line H/D exchange

• Forced degradation studies were carried out on fosinopril.
• LC-MS tools were used for characterization of its degradation products.
• Mass fragmentation profiles were established for the drug and degradation products.
• Degradation pathway of the drug was laid down.

Fosinopril was subjected to stress degradation studies under hydrolytic (acidic, basic and neutral), oxidative, photolytic and thermal stress conditions. The drug underwent degradation in hydrolytic and photo acidic conditions, while it was stable to oxidative and thermal stress. The degradation products (DPs) were detected after using a gradient LC-MS method. These were characterized using a protocol involving comparison of mass fragmentation pathways of the drug and the DPs, and consideration of mass data generated during MS/TOF, MSn and H/D exchange studies. The degradation pathway of the drug was established, which was duly justified by mechanistic explanation.

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