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作 者:钱俊[1] 林夏[1] 王星星[1] 刘莉莉[1] 吴云[1] 萧伟[1]
机构地区:[1]江苏康缘药业股份有限公司中药制药过程新技术国家重点实验室,连云港222001
出 处:《药学与临床研究》2014年第3期219-221,共3页Pharmaceutical and Clinical Research
摘 要:目的:建立妇科Ⅳ颗粒剂中芍药苷和虎杖苷含量的HPLC测定方法。方法:采用Phenomenex Luna C18(4.6 mm×250 mm,5μm)色谱柱;流动相为乙腈-0.1%磷酸(17∶83);流速为1.0 mL·min-1;柱温为30℃;检测波长为230 nm、306 nm。结果:芍药苷在0.524-8.384μg、虎杖苷在0.344-5.502μg范围内,进样量与峰面积具有良好线性关系(r=0.9997,r=0.9999),平均回收率分别为99.6%(RSD=0.92%)、100.3%(RSD=1.32%)。结论:研究建立的含量测定方法可靠、准确、重现性好,可用于该制剂的质量控制。Objective: An HPLC-UV method was developed for the determination of paeoniflorin and polydatin in Fuke Ⅳ granules. Methods: The optimal conditions of separation and detection were achieved on a Phenomenex Luna C18(4.6 mm×250 mm, 5 μm) analytical column with an mobile phase consisting of acetonitrile-0.1% phosphoric acid(17∶83) at the flow-rate of 1 mL·min-1, The column temperature was 35 ℃and the UV detection wavelength was 230 nm and 306 nm respectively. Results: The calibration curves for paeoniflorin and polydatin were linear over the range of 0.524 μg -8.384 μg and 0.344 μg -5.502 μg respectively. The recoveries were 99.6% and 100.3% with RSD 0.92% and 1.32%(n =6), respectively.Conclusion: The method is simple and reliable with good reproducibility and can be used to control the quality of the granules.
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