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作 者:崔雅慧 金志国 CUI Yahui;JIN Zhiguo(Pharmacy Department of Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China)
机构地区:[1]首都医科大学附属北京世纪坛医院药剂科,北京100038
出 处:《中国临床药学杂志》2021年第1期18-21,共4页Chinese Journal of Clinical Pharmacy
摘 要:目的建立用于测定伊痛舒注射液中细辛脂素、阿魏酸和欧前胡素3种成分含量的RP-HPLC法。方法采用Capcell PAKC18色谱柱(250 mm×4.6 mm,5μm)分离;柱温26℃;检测波长306 nm;流速1.0 m L·min^(-1);进样体积25μL;流动相:0.1%磷酸溶液(A)-乙腈(B),梯度洗脱(0~6 min时13%B,6~28 min 13%~62%B,28~30 min 62%~13%B,30~35min 13%B)。结果细辛脂素、阿魏酸和欧前胡素在质量浓度0.2~20.0 mg·L^(-1)内,线性关系良好;平均加标回收率分别为101.09%、100.60%和99.81%;仪器精密度的RSD≤5%,重复性RSD(n=6)分别为2.5%、3.1%和2.8%;供试品溶液在24 h内稳定。结论方法具有简便、快速、准确等特点,可以用于伊痛舒注射液产品的质量控制。AIM To establish an analytical method for determination of contents of asarinin, ferulic acid and imperatorin in Yitongshu injection by reverse high performance liquid chromatography(RP-HPLC). METHODS Capcell PAK C18 column(250 mm×4.6 mm, 5 μm) was used for seperation, column temperature was set at 26 ℃, detection wavelength was set at 306 nm and sample size was 25 μL. The flow rate was 1.0 mL·min^(-1). The mobile phase was 0.1% phosphoric acid solution(A) and acetonitrile(gradient elution). Gradient elution procedure :(0-6 min 13% B, 6-28 min 13%-62% B, 28-30 min 62%-13% B, and 30-35 min 13% B). RESULTS Asarinin, ferulic acid and imperatorin showed good linear relationships in the range of 0.2-20.0 mg·L^(-1). Average recoveries of 3 components were 101.09%, 100.60% and 99.81%, respectively. Relative standard deviation(RSD) of precision of instrument used did not exceed 5%. RSD of repeatiability(n=6) was 2.5%, 3.1% and 2.8%, respectively. Sample solution was stable within 24 h. CONCLUSION This method is simple, fast and accurate, and can be used for quality control of Yitongshu injection.
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