Vinay Wamorkar, Manjunath S.Y., Ramaa C.S.

Study Of Degradants From Stability Trials Of API

Isolation & Characterization Of Degradents Of API

• Broschiertes Buch

Produktbeschreibung

Stability stuidies are performed to access the shelf-life of bulk drugs as well as formulations. This step in essential to ensure saftey, efficiency and efficacy of pharmaceutical. In present work Voriconazole was selected as a model drug for accelerated as well as forced degradation studies. To study the probable degradents various conditions such as acid/alkali, oxidation, light dry heat were conducted. For isolation of these products HPTLC method was developed and validated. Also stability indicating HPLC method was developed and validated. The degradents so generated were isolated by preparative HPTLC. The purity of degradents were confirmed by HPLC method which previously validated using 1:1 v/v of acetonitrile:water as mobile phase. The degradents so isolated, subjected for characterization by Mass Spectroscopy & probable structures and mass were estimated. From these studies it was found that voriconazole was stable under dry conditions, but extremly susceptible for hydrolysis in acidic/alkaline & netral conditions.

Produktdetails

• Verlag: LAP Lambert Academic Publishing
• Aufl.
• Seitenzahl: 96
• Englisch
• ISBN-13: 9783659132179
• ISBN-10: 3659132179
• Artikelnr.: 36123494

Autorenporträt

Vinay Vijay Wamorkarm.Pharm (PhD)life Member Of Aptiassistant Professor Srikrupa Institute Of Pharmaceutical Sciences Published Research Articles In Various International And National Journals Research Experience Of 08 Yearsarea Of Specialization: Oral Control And Sustained Release Formulations,NDDS,HPLC/TLC Method Development And Validation