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机构地区:[1]深圳市药品检验所,518029
出 处:《中国药品标准》2002年第4期48-50,共3页Drug Standards of China
摘 要:目的:建立测定盐酸索他洛尔片含量的HPLC测定法。方法:采用Nova-Pak C_(18)色谱柱;以0.02%庚烷磺酸钠(稀磷酸调pH3.0)-乙腈(80:20)为流动相;检测波长为228nm。结果:在10.3-92.8μg/ml的浓度范围内线性关系良好,r=0.9999,平均回收率为99.95%(n=5),RSD=0.60%。重复进样RSD=0.2%(n=5)。结论:本方法简便、快速、准确,重现性好,适用于盐酸索他洛尔片的含量测定及其质量控制。Objective: To establish a HPLC method for the determination of Sotalol HydrochlorideTablets. Methods: Chromatographed conditionincluded column: Nova-Pak C_(18); mobile phase: 0.02% sodi-um heptanesulfonate (adjust pH to 3.0 with diluted phosphoric acid)-acetonitrile(80:20);detection wave-length: 228nm. Results: There was a good linear relationship between the concentration of sotalol and ab-sorption area. value in the range of 10.3-92.8μg/ml,r=0.9999. The average recovery was 99.95%withRSD 0.60% (n=5 ). The RSD for repetition was 0.2% (n=5). Conclusion: The method was simple,rapid,accurate and suitable for quality and quantity control of Sotalol Hydrochloride Tablets.
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