Forced degradation of timolol maleate on high temperature for verification of HPLC method for related substances in Timolol eye drop 0.5%

Timolol is a potent β-adrenergic blocker, useful in treatment of ocular hypertension or open-angle glaucoma.
Many chromatographic analysis methods have been applied for the determination of pharmaceutical compounds containing heterocyclic rings (as timolol maleate), but the most commonly applied chromatographic technique is HPLC.
Understanding the stability characteristics for both the active pharmaceutical ingredient (API) and for the drug product (DP) is crucial for the development of a safe and effective pharmaceutical agent. For this purpose, samples from API and DP during product development are disposed under strictly controlled storage conditions to assess stability testing. Forced degradation studies are being conducted to identify the degradation products that are likely to occur during long term storage as the worst- case scenario.