Study Of Degradants From Stability Trials Of API » książka
Study Of Degradants From Stability Trials Of API
ISBN-13: 9783659132179 / Angielski / Miękka / 2012 / 96 str.
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
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.
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