HPLC法测定复方甲硝唑含漱液中甲硝唑、呋喃西林含量 药学毕业论文(设计)四篇.docVIP

HPLC法测定复方甲硝唑含漱液中甲硝唑、呋喃西林含量 摘 要 目的 建立同时测定复方甲硝唑漱口液中甲硝唑、呋喃西林含量的高效液相色谱法。方法 采用Lichrospher C18(5 μm, 4.6×250 mm) 色谱柱，乙腈-水(20:80)为流动相(1%磷酸，三乙胺调pH 3.8)，检测波长为263 nm，流速为1.0 mL·min-1，柱温为35 ℃。 结果 甲硝唑和呋喃西林的线性范围分别为 603~1407 μg·mL-1 (γ=0.9999)， 9.603~21.34 μg·mL-1 (γ=0.9987)。回收率分别为100.8%(RSD=0.41%~2.50%)，99.5%(RSD=0.20%~4.16%)；日内RSD为0.17%~0.20%和0.76%~2.31%，n=5；日间RSD为0.10%~0.43%和0.13%~0.20%，n=4。结论 HPLC法可用于复方甲硝唑漱口液的含量测定，方法准确、灵敏，专属性强。 关键词： 高效液相色谱法；甲硝唑；呋喃西林；漱口液 Determination of Metronidazole and Furacilin with HPLC Method ABSTRACT: Objective: To establish a HPLC method for simultaneous determination of metronidazole and furacilin in its Collut. Methods: A Lichrospher C18(5 μm,4.6×250 mm) column was used, the mobile phase was acetonirile-water(20:80) containing 1% phosphonic acid, which was adjusted to pH3.8 by TEA. The detection wavelength was 263nm and the flow number was 1 mL·min-1.The column temperature was kept at 35℃. Results: The linear ranges of metrondazole and furacilin were 603~1407 μg·mL-1(γ=0.99993) and 9.603~21.34 μg·mL-1(γ=0.99872), respectively. The recoveries were 100.8% (RSD: 0.41%~2.50%) and 99.5% (RSD: 0.20%~4.16%), respectively. The RSD of inter-day of two were 0.17%~0.20% and 0.76%~2.31%, n=5.The RSD of inter-day of two constituents were 0.10%~0.43% and 0.13% ~0.20%. Conclusion: The method is accurate, sensitive for compound metrondazole collut. KEY WORDS: HPLC, Metronidazole, Furacilin, Collut 复方甲硝唑含漱液为瑞金医院自制制剂，主要是由甲硝唑、呋喃西林、醋酸氯己定（醋酸洗必泰）及辅料甘油、薄荷、甜蜜素等组成。临床用于治疗牙龈出血、牙周肿痛、口腔溃疡及溢脓口臭等口腔疾病。本文建立了反相高效液相色谱法同时分离和测定甲硝唑和呋喃西林的含量，方法准确、简便、灵敏，适用于制剂的质量控制。 仪器与试药 1.1 仪器 Waters 高效液相色谱仪，包括510型CM, TCM，Empower 色谱管理软件（美国Waters公司）；BS224S型电子分析天平（sartorius公司）；Milli-Q超纯水系统（美国Millipore）； CQ50型超声波清洗器（上海超声波仪器厂）；DELTA-320pH计（梅特勒-托力多仪器上海有限公司）；XW-80A型旋涡混合器（上海医大仪器厂）；TXL-16型高速离心机（上海安亭科学仪器厂）。 1.2 试剂 甲硝唑(武汉武药制药有限公司，批号：C04、呋喃西林(厦门东风药业有限公司)的对照品（中国药品生物制品检定所，批号；甲醇（色谱纯，TEDIA）；其它试剂均为分析纯。复方甲硝唑含漱液2批（批号：20070821），不含药物的空白溶液由我院制剂室制备。 方法与结果 2.1 色谱条件与系统适应性 色谱柱 Lichrospher