HPLC and LC-MS evaluation of stress degradation behaviour of escitalopram oxalate and development of a validated stability ind

In the present study, comprehensive stress testing of Dexketoprofen trometamol was carried out according to ICH guideline Q1A (R2). Dexketoprofen trometamol is subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Additionally, the solid drug is subjected to 50 °C for 60 days in dry-bath, and to the combined effect of temperature and humidity, with and without light, at 40°C/75% RH. The drug was found to degrade significantly in oxidative and photo condition whereas it is found to be stable in acidic, alkaline and neutral condition. The drug is relatively stable in the solid-state, except formation of minor products under accelerated conditions. Successful separation of drug from degradation products formed under stress conditions is achieved on a Thermo Hypersil BDS–C18