Analysis of recombinant monoclonal antibodies in hydrophilic interaction chromatography: A generic method development approach
نویسندگان
چکیده
منابع مشابه
Development of Hydrophilic Interaction Liquid Chromatography Method for the Analysis of Moxonidine and Its Impurities
Fast and simple hydrophilic interaction liquid chromatography (HILIC) method was developed and validated for the analysis of moxonidine and its four impurities (A, B, C, and D) in pharmaceutical dosage form. All experiments were performed on the Agilent Technologies 1200 high-performance liquid chromatography (HPLC) system using Zorbax RX-SIL, 250 mm × 4.6 mm, 5 μm column as stationary phase (T...
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In the early 1990s, hydrophilic interaction (liquid) chromatography (HILIC) emerged as a new separation method. HILIC is becoming increasingly popular for the separation of polar compounds in aqueous-organic mobile phases rich in organic solvents (usually acetonitrile). It has become important for the separation of pharmaceuticals, neurotransmitters, nucleosides, nucleotides and other compounds...
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CD19 is expressed on B- lineage cells and follicular dendritic cells and plays a key role in B cell malignancies and autoimmune diseases. Thus, it has been considered as potential target for several monoclonal antibodies (mAbs). For decades, chemotherapy has been known as one of the major antitumor therapies eradicating high proliferative tumor cells. But, anti- CD19 mAbs developed for treating...
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In this paper, chromatographic analysis of active substance olopatadine hydrochloride, which is used in eye drops as antihistaminic agent, and its impurity E isomer by hydrophilic interaction liquid chromatography (HILIC) and application of design of experiments (DoE) methodology are presented. In addition, benzalkonium chloride is very often used as a preservative in eye drops. Therefore, the ...
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IN T RO DU C T IO N Metformin hydrochloride is an anti-diabetic drug typically administered orally while treating non-insulin dependant (type 2) diabetes mellitus.1 It is one of the most widely-used oral antidiabetic drugs worldwide, with over 48 million generic formulation prescriptions filled in the United States alone.2 Liquid chromatographic analysis of metformin and related impurities pres...
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ژورنال
عنوان ژورنال: Journal of Pharmaceutical and Biomedical Analysis
سال: 2017
ISSN: 0731-7085
DOI: 10.1016/j.jpba.2017.06.016