Development and Validation of Stability Indicating Method for Darunavir with Forced Degradation Studies Using LC-ESI-MS/MS
نویسندگان
چکیده
منابع مشابه
Stability Indicating HPLC Method Development and Validation
High performance liquid chromatography (HPLC) is an integral analytical tool in assessing drug product stability. HPLC methods should be able to separate, detect, and quantify the various drug-related degradants that can form on storage or manufacturing, plus detect and quantify any drug-related impurities that may be introduced during synthesis. Forced degradation studies of new chemical entit...
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A simple stability-indicating HPLC-DAD method was validated for the determination of ferulic acid (FA) in polymeric microparticles. Chromatographic conditions consisted of a RP C18 column (250 mm × 4.60 mm, 5 μm, 110 Å) using a mixture of methanol and water pH 3.0 (48 : 52 v/v) as mobile phase at a flow rate of 1.0 mL/min with UV detection at 320 nm. The developed method was validated as per IC...
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Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Forced degradation s...
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ژورنال
عنوان ژورنال: Asian Journal of Chemistry
سال: 2016
ISSN: 0970-7077,0975-427X
DOI: 10.14233/ajchem.2016.19806