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目的采用HPLC-UV法同时测定肾康注射液中的4种成分(大黄酸、大黄素、丹参素、羟基红花黄色素A)。方法采用Sino Chrom ODS-BP色谱柱(250 mm×4.6 mm,5μm),以甲醇(A)-1.0‰甲酸水(B)溶液为流动相进行梯度洗脱(0~6 min、10%A,6~15 min、10%A→30%A,15~32 min、30%A→95%A,32~36 min、95%A),流速1 m L·min~(-1),进样量20μL,柱温30℃,检测波长270 nm。结果大黄酸、大黄素、丹参素、羟基红花黄色素A的线性范围分别为1.5~48.0、0.02~0.64、0.0338~1.0820、0.0473~1.5130μg·m L~(-1)(r≥0.9992),浓度与峰面积具有良好的线性关系;大黄酸、大黄素、丹参素、羟基红花黄色素A的平均加样回收率分别为98.12%、97.39%、97.62%、97.72%,RSD分别为1.19%、2.36%、2.55%、2.01%。结论所用方法准确、快速、灵敏、重复性好,可为肾康注射液的质量控制提供参考。
OBJECTIVE To determine the four components (rhein, emodin, danshensu, hydroxysafflor yellow A) in Shenkang injection simultaneously by HPLC-UV method. METHODS The gradient elution was performed on a SinoChrom ODS-BP column (250 mm × 4.6 mm, 5 μm) using a mobile phase of methanol (A) -1.0 ‰ formic acid (B) for 0-6 min, 10% A, 6-15 min, 10% A → 30% A, 15-32 min, 30% A → 95% A, 32-36 min, 95% A) at a flow rate of 1 m L · min -1 Volume 20μL, column temperature 30 ℃, detection wavelength 270 nm. Results The linear ranges of rhein, emodin, danshensu, hydroxysafflor yellow A were 1.5 ~ 48.0,0.02 ~ 0.64,0.0338 ~ 1.0820,0.0473 ~ 1.5130μg · m L -1 (r≥0.9992) The average recoveries of rhein, emodin, danshensu and hydroxysafflor yellow A were 98.12%, 97.39%, 97.62% and 97.72%, respectively, with RSDs of 1.19 %, 2.36%, 2.55%, 2.01%. Conclusion The method is accurate, rapid, sensitive and reproducible, which can provide reference for the quality control of Shenkang injection.