Stability Indicating RP- HPLC Method for Determination of Almotriptan. RP- HPLC study for Almotriptan

      Аннотация: Identification and quantification of impurities is a crucial task in pharmaceutical process development for quality and safety. Related components are the impurities in pharmaceuticals which are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during stability testing, or develop during formulation or upon aging of both API and formulated APIs to medicines. The presence of these unwanted chemicals even in small amounts may influence the efficacy and safety of the pharmaceutical products. Various analytical methodologies are employed for the determination of related components in pharmaceuticals. There is a great need for development of new analytical methods for quality evaluation of new emerging drugs. The ICH guideline which deals with “Stability Testing of new Drug Substances and Products” plays a vital role in establishing the stability of bulk drugs as well as the pharmaceutical formulations. The present work aimed at developing RP-HPLC method for Almotriptan and to carry out stability studies at different stress conditions.

Ключевые слова: Almotriptan, RP- HPLC, ICH guideline, stability study