盐酸文拉法辛缓释胶囊-USP标准.pdfVIP

undefinedUSP Monographs: Venlafaxine Hydrochloride Extended-Release... 页码，1/8 Add the following: Venlafaxine Hydrochloride Extended-Release Capsules DEFINITION Venlafaxine Hydrochloride Extended-Release Capsules contain an amount of Venlafaxine Hydrochloride equivalent to NLT 90.0% and NMT 110.0% of the labeled amount of venlafaxine (C H NO ). 17 27 2 IDENTIFICATION • A. ULTRAVIOLET ABSORPTION 197U – Wavelength range: 250 310 nm • B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. ASSAY • PROCEDURE Mobile phase: Acetonitrile, triethylamine, and water (250:4:750). Adjust with phosphoric acid to a pH of 3.5. Standard solution: 0.25 mg/mL of USP Venlafaxine Hydrochloride RS in Mobile phase Sample stock solution: Nominally 1.0 mg/mL of venlafaxine (from the contents of NLT 10 Capsules) prepared as follows. Transfer a weighed quantity of Capsule contents to a suitable volumetric flask. Add 8% of the flask volume of acetonitrile, and shake for 40 min. Add 50% of flask volume of Mobile phase, and shake for an additional 20 min. Dilute with Mobile phase to volume. Pass a portion through a suitable filter of 0.45-µm pore size. Sample solution: 0.25 mg/mL of venlafaxine (using the filtrate from the Sample stock solution) in Mobile phase Chromatographic system (See Chromatography 621 , System Suitability.) Mode: LC Detector: UV 226 nm × Column: 4.6-mm 25-cm; 5-µm packing L1 Flow rate: 1 mL/min Injection volume: 10 µL Run time: 1.5 times the retention time of venlafaxine System suitability Sample: Standard solution Su