复方颠茄口服溶液中硫酸阿托品含量测定及质量标准研究

目的:建立复方颠茄口服溶液的质量控制标准。方法: 利用反相高效液相色谱法对制剂中硫酸阿托品、东莨菪碱及山莨菪碱进行定性鉴别;采用反相高效液相色谱法测定硫酸阿托品的含量。色谱条件:以十八烷基硅烷键合硅胶为填充剂;以乙腈-磷酸盐缓冲液(pH 2.8)(10:90)为流动相;检测波长为210 nm;流速为1.0 mL·min^-1;进样量为。结果: 样品溶液色谱图中显示与对照品溶液色谱图中相同的硫酸阿托品、东莨菪碱及山莨菪碱色谱峰,且分离度良好,硫酸阿托品在15.29~152.9。结论: 该方法准确、可靠、专属性强,为建立复方颠茄口服溶液质量标准提供依据。

Objective: To establish a quality standard for compound belladonna oral solution.Method: RP-HPLC method was adopted for the Atropine Sulfate,Scopolamine and Anisodamine identification,and the content of Atropine Sulfate was also determined.The analyses were performed on a CAPCELL PAK C₁₈ column(4.6 mm×150 mm,5 μm) with the mobile phase consisted of acetonitrile-phosphate buffer(pH 2.8)(10:90) at a flow rate of 1.0 mL·min^-1.The detection wavelength was 210nm,the temperature of column was 30℃,and the volume of injection was 20μL. Results: The chromatogram of the sample solution showed three peaks which were similar to the reference solution.The linear range of atropine sulfate was in the range of 15.29-152.9μg·mL^-1(r=0.9996),the average recovery(n=6) was 100.2% and the RSD was 1.7%.Conclusion: The method is accurate,reliable and specific,which can be used for the quality control of compound belladonna oral solution.

1 ChP(中国药典).2010.Vol Ⅰ(一部):397
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