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高效液相色谱-紫外分光光度法测定奥美沙坦酯片剂的含量及有关物质

Determination of Olmesartan Medoxmil and Related Substance in Its Tablets by HPLC-UV
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摘要 目的采用高效液相色谱法测定奥美沙坦酯片的含量及有关物质。方法采用美国Alltech C18色谱柱(150 mm×4.6 mm,5μm),以0.1%甲酸水溶液-乙腈(67.5∶32.5)为流动相;流速为1.0 mL/min;柱温为25℃,波长为254 nm,进样量为10μL。结果含量测定的线性范围为0.50~10.00μg/mL,r=0.999 5(n=5),加样回收率为101.1%,99.5%,98.3%;RSD依次为1.2%,0.7,0.3%(n=5)。结论该方法简便快速、准确,专属性好。 Objective To establish an HPLC-UV method for the determination of olmesartan medoxmil and related sustances in its tablets.Methods Using a Waters symmatry C 18 column(150 mm × 4.6 mm,5 μm).The mobile phase consisted of 0.1% triethylamine(pH was adjusted to 2.8 using phosphoric acid)-acetomitrile(67.5: 32.5).The flow rate was 1.0 mL/min with UV detection set at 254 nm.The column temperature was 25 ℃.Inject volume was 10 μL.Results The linear range for the content of olmesartan medoxmil was 0.50-10.00 μg/mL,r = 0.999 3(n = 5).The recoveries of olmesartan medoxmil tablets were 101.1%,99.5%,98.3% and its RSD were 1.2%,0.7%,0.3%(n = 5).Conclusion The method is simple,rapid,accurente and is suitable for the determination of olmesartan medoxmil and its related substances.
出处 《中国药业》 CAS 2013年第1期22-24,共3页 China Pharmaceuticals
关键词 奥美沙坦酯 片剂 高效液相色谱法 含量测定 有关物质 olmesartan medoxmil tablets HPLC-UV content determination related sustances
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