Forced degradation of Romprogestin 1% for HPLC-method development and drug stability assessment
Journal Title: Medicamentul Veterinar / Veterinary Drug - Year 2018, Vol 12, Issue 1
Abstract
Forced degradation is an analytical technique applied to a drug product in order to simulate conditions more severe than those in accelerated stability studies. Active substances may suffer degradation during storage over drugs shelf-life; degradation products and degradation pathways should be elucidated to demonstrate the stability of the medicinal product. The oily injection of progesterone is used to synchronize oestrus in ruminants or to treat various clinical manifestations in dogs and cats. Degradation of drug substances between 5 % and 20 % has been accepted as reasonable for validation of chromatographic assays [3]. The chemical methods used for forced degradation of Romprogestin 1 % injectable solution were: acid hydrolysis, basic hydrolysis and oxidation; the physical method used was the influence of temperature increase. Some parameters were evaluated for validation of the HPLC method (specificity, linearity, detection limit, etc.).
Authors and Affiliations
Mădălina Enciu, Viorica Chiurciu, Elena Gabriela Oltean, Adrian G. Nica
Keywords
Related Articles
- EP ID EP304242
- DOI -
- Views 119
- Downloads 0
Preliminary data regarding some pain manifestations in a MPTP- induced rat model of Parkinson’s disease
Parkinson's disease (PD) is less known as a disease causing pain syndromes, although pain is found in 40-80 % of PD patients, as described by the very few reports in this area of research. Moreover, in some PD patients,...
Disinfection air and surfaces: contemporary fine by forming a 5 mm without wetting on the basis of hydrogen peroxide – nocolyse generated by nebulizer Nocospray
Nocospray is a revolutionary concept for bio professional disinfection, with bactericidal, virucidal, fungicidal and sporicidal effect using hydrogen peroxide as the active substance in combination with colloidal silver,...
The thyroid and the thyroid hormones
The thyroid gland is located in the cervical fascia were it is divided in two lateral lobes, right and left, disposed on both sides of the trachea, and unlike other vertebrates, the cat does not have an isthmus that conn...
Dezvoltarea şi validarea metodei RP–HPLC de determinare cantitativă a metronidazolului din comprimate şi pulberi
A fost dezvoltată şi validată o metodă isocratică de lichid cromatografie de performanţă înaltă pentru determinarea cantitativă a metronidazol din comprimate şi pulberi. Separarea HPLC a fost realizată prin cromatografie...
Substances that disrupt thyroid hormone biosynthesis
Endocrine disrupters are natural or synthetic chemical substances that have the possibility to alter the endocrine functions leading to serious metabolic changes especially in newborns. The accumulation and persistence o...