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LC-UV and LC-MS evaluation of stress degradation behavior of desvenlafaxine

Journal of Pharmaceutical Analysis 2012年第4期2卷 264-271页

作者： Shubhangi M.Pawar Laxman D.Khatal Satish Y.Gabhe Sunil R.Dhaneshwar Research and Development Centre in Pharmaceutical Sciences and Applied Chemistry Poona College of PharmacyBharati Vidyapeeth University Bioanalytical Research Department BioAnalytical Technologies Pvt.Ltd.

The objective of current study was to develop a validated specific stability indicating reversed-phase liquid chromatographic method for the quantitative determination of desvenlafaxine in bulk sample and pharmaceutical dosage form in the presence of degradation products. Forced degradation studies were performed on bulk sample of desvenlafaxine as per ICH prescribed stress conditions using acid, base, oxidative and photolytic degradation to show the stability indicating power of the method. Significant degradation was observed under acidic stress condition and the degradation product formed was identified by LC-MS and a degradation pathway for drug has been proposed. Successful separation of drug from degradation products formed under stress conditions was achieved on a SymmetryShield column C 18 (5 mm, 250 mm 4.6 mm, i.d.) using the mobile phase consisting of a mixture of 0.2% (v/v) triethylamine in ammonium acetate (0.05 M; pH 6.5) and methanol using isocratic gradient.

关键词： Reversed-phase liquid chromatography Liquid chromatography mass spectrometer (LC/MS) desvenlafaxine Stress studies Validation Degradation

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Development and <i>in Vitro-in Vivo</i>Evaluation of Controlled Release Matrix Tablets of desvenlafaxine

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Pharmacology & Pharmacy 2012年第1期3卷 15-19页

作者： Shashidhar Reddy Dodda Prakash Rao B 不详

The objective of this investigation was to prepare extended release tablet containing matrix granules of desvenlafaxine succinate monohydrate and to study its in vitro release and in vivo absorption. The design of dosage form was performed by choosing hydrophilic hydroxypropyl methyl cellulose (HPMC K100M), sodium carboxyl methyl cellulose (Blanose), microcrystalline cellulose (MCC) and lactose monohydrate polymers as matrix builders and polyvinyl pyrolidine (Kollidon K30) as granulating polymers. Granules were prepared by composing drug with HPMC K100M, sodium CMC, MCC and lactose monohydrate by spray drying method. Optimized formulation of desvenlafaxine succinate monohydrate was formed by using 20% HPMC K100M, 26.6% MCC, 6.6% of sodium CMC (Blanose), 13.3% of lactose monohydrate and 5% ratio of Kollidon K30 as binder. Tablets were compressed with free flowing optimized granules of uniform drug content. This extended the release period up to 24 h in vitro study. Similarity factor and mean dissolution time were also reported to compare various dissolution profiles. The network formed by HPMC, MCC and Blanose had been coupled satisfactorily with the controlled resistance. Biopharmaceutical study of this optimized dosage form in rabbit model showed 24 h prolonged drug release in vivo. A close correlation (R2 = 0.9833) was established between the in vitro release and the in vivo absorption of drug. The results suggested that wet granulation with spray dried technique, is a suitable method to formulate sustained release desvenlafaxine succinate monohydrate and it can Perform therapeutically better than conventional immediate release dosage form.

关键词： desvenlafaxine Pharmacokinetics ER Matrix Tablet In Vitro Kinetics Depressio

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