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HPLC法测定枸橼酸西地那非阴道栓的含量 被引量:3

Determination of sildenafil citrate by HPLC
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摘要 目的建立枸橼酸西地那非阴道栓的含量测定方法,以控制其产品质量。方法采用高效液相色谱测定法。C18色谱柱。流动相为:0.05mol.L-1磷酸三乙胺(0.7%三乙胺1000mL用磷酸调节pH3.0)甲醇-乙腈(52∶30∶18),检测波长290nm。结果在10μg^60μg.mL-1范围内峰面积与西地那非浓度成良好的线形关系,加样回收率和RSD分别为99.0%和0.6%。结论方法简便准确,可用于制剂的质量分析。 OBJECTIVE To establish a HPLC method for the determination of sildenafil citrate. METHODS The column was used and the mobile phase was 0.05 mol·L^-1 phosphate triethylamine (0.7% triethylamine 1000mL pH adjusted to 3.0 with H3PO4)-methanol-acetonitrile (52 : 30 : 18),the detective wavelength was 290nm, RESULTS The peak area versus sildenafil citrate concentration proved linear in the range of 10μg- 60μg · mL^-1. The recovery was 99, 0%, RSD was 0.6 %. CONCLUSION The method is simple and accurate and could be used for the quality control of sildenafil citrate preparations.
出处 《海峡药学》 2007年第1期36-37,共2页 Strait Pharmaceutical Journal
关键词 橼酸西地那非 橼酸西地那非阴道栓 HPLC Sildena citrate Sildena citrate intravaginal suppositories HPLC
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  • 1FDA.Center for drug evaluation and research[R].Application Num ber 020895.1998,3:27.

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