Forced Degradation Studies Of Pimecrolimus As Per ICH Guidelines
نویسندگان
چکیده
Forced degradation studies are used to validate analytical procedures for the drug substance and products. of Pimecrolimus its cream were performed under stressed alkaline, acidic, oxidative thermal conditions according ICH guidelines Q1A(R2). A sensitive stability indicating RP-HPLC method was purposed validated separation Desmethyl Pimecrolimus. The chromatographic achieved with Phenomenax Luna, C18, 150 x 4.6mm 3µm particle size column. flow rate 1.5 mL/min eluents detected at 210nm using PDA detector. For examination associated compounds, our newly designed HPLC approach proved extremely exact, specific, reliable, accurate.
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ژورنال
عنوان ژورنال: Journal of Pharmaceutical Negative Results
سال: 2022
ISSN: ['0976-9234', '2229-7723']
DOI: https://doi.org/10.47750/pnr.2022.13.s09.654