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HPLC法和分光光度法测定茴三硫片含量的比较(1)
http://www.100md.com 2011年7月5日 汪加龙 刘丛彬
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     [摘要] 目的:运用高效液相色谱法和紫外-可见分光光度法对茴三硫片含量进行测定,并对方法学和测定结果进行比较。方法:色谱法中色谱柱Kromasil C18柱(4.6 mm ×250 mm,5 μm),以甲醇-水(80∶20)为流动相,检测波长为432 nm;分光光度法于432 nm波长处以外标法测定。结果:HPLC法在32.5~250.0 μg/ml浓度范围内其浓度与峰面积呈良好线性关系(r=0.999 9),平均空白回收率为99.68%(RSD=0.46%,n=9);分光光度法在4.096~20.480 μg/ml浓度范围内其浓度与吸光度呈良好线性关系(r=0.999 4),平均回收率为99.96%(RSD=0.44%,n=9);三批样品的平均含量测定结果为:HPLC法分别为99.25%、99.14%和99.10%,分光光度法分别为99.46%、99.22%和99.13%。结论:两种方法均能准确测定茴三硫片的含量,可作为其质量控制的方法。

    [关键词] 茴三硫片;HPLC;分光光度法;含量

    [中图分类号] R917 [文献标识码] A [文章编号] 1673-7210(2011)07(a)-057-03

    Comparison of the content assay of Anetholetrithione Tablets determined by HPLC and visible spectrophotometry

    WANG Jialong1, LIU Congbin2

    1.Pharmacy Department Office, People's Hospital of Shucheng, Shucheng 231300, China; 2. School of Pharmacy, Anhui College of Traditional Chinese Medicine, Hefei 230038, China

    [Abstract] Objective: To compare the HPLC and visible spectrophotometry methods in assaying Anetholetrithione Tablets, and the methodology and results were compared respectively. Methods: Kromasil C18 (4.6 mm×250 mm,5 μm) was used with mobile phase of methanol-water (80∶20) and the detective wavelength was set at 432 nm in HPLC method; the detective wavelength was set at 432 nm in visible spectrophotometry method. Results: The linear range of anetholtrithione was 32.5-250.0 μg/ml (r=0.999 9), and the average recovery was 99.68% with RSD 0.46%(n=9) in HPLC method; the visible spectrophotometry method was 4.096-20.480 μg/ml (r=0.999 4), and the average recovery was 99.96% with RSD 0.44%(n=9). The average assay results of three batches of samples: HPLC method was 99.25%, 99.14% and 99.10%, visible spectrophotometry method was 99.46%,99.22% and 99.13%. Conclusion: Both methods can accurately determine Anetholetrithione Tablets, and can be used as the quality control methods of it.

    [Key words] Anetholetrithione Tablets; HPLC; Visible spectrophotometry; Content determination

    茴三硫又名胆维他,其药理作用广泛,具有保护肝细胞、利胆、抗氧化、降低血中胆固醇、促进唾液分泌、防癌、抑制血小板聚集、调节免疫、治疗口干等作用。临床上主要用于治疗慢性肝炎、高脂血症、脂肪肝等,鉴于其疗效确切,毒副作用低而被德国、法国、日本和澳大利亚及台湾等发达国家和地区广泛使用[1] ......

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