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THE PHARMA REVIEW (JULY - AUGUST 2012)

Stress Degradation Studies and Development of Validated Stability Indicating Method for Assay of Olanzapine

Ahmed Reema Ha1, Bhusari K.P1, Tajne M.R2

Introduction:
 
The drugs may get contaminated with process impurities1 during their formulation they may also undergo degradation under environmental conditions leading to contamination with degradation products thereby lowering/altering the therapeutic efficacy and safety. Drug regulatory authorities around the world require that impurities in drug substance and drug product when present at threshold levels recommended by the International Conference on Harmonisation (ICH)* be isolated and characterized. The identification of process related impurities and degradation products can provide an understanding on production of impurities and degradation mechanism Degradation product is a molecule resulting from a change in the drug substance brought about over time which could occur as a result of processing or storage. The term drug stability refers to extent to which drug substance or product retain, within specified limit throughout its period storage and having same properties and characteristics those were present at the time of manufacturing. According to US FDA guidelines Stability Indicating Method (SIM) is defined as validated analytical procedure that accurately and precisely measure Active Pharmaceutical Ingredient (API) free from potential interferences like degradation products, process impurities, and other potential impurities. The probable degradation product of API can be produced certain stress conditions like hydrolytic (acidic, basic, etc), oxidative, thermal, photolytic, etc. The aim of this work was to develop SIM for determination of Olanzapine in presence of its degradation products. In the present study, stress degradation of Olanzapine was effected by hydrolysis under acidic, basic, conditions, oxidation with H2O2, dry heat degradation, and photo degradation.

 

 

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