HPLC法同时测定舒肝宁注射液中5 种成分的含量
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篇名: HPLC法同时测定舒肝宁注射液中5 种成分的含量
TITLE:
摘要: 目的:建立同时测定舒肝宁注射液中5种成分含量的方法。方法:采用高效液相色谱法。色谱柱为Symmetry® C18,流动相为甲醇-0.4%磷酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长为238 nm(栀子苷、黄芩苷)、327 nm(绿原酸、野黄芩苷、黄芩素),柱温为30 ℃,进样量为10 μL。结果:绿原酸、栀子苷、黄芩苷、黄芩素、野黄芩苷检测质量浓度线性范围分别为0.406 2~26.0 μg/mL(r=0.999 9)、2.500 0~160.0 μg/mL(r=0.999 9)、6.562 0~420.0 μg/mL(r=0.999 9)、0.312 5~20.0 μg/mL(r=0.999 6)、0.585 9~37.5 μg/mL(r=0.999 8);定量限≤31.20 ng,检测限≤15.60 ng;精密度、稳定性、重复性试验的RSD<2.0%;加样回收率分别为97.72%~101.10%(RSD=1.21%,n= 6)、97.67%~102.40%(RSD=1.87%,n=6)、97.64%~101.10%(RSD=1.31%,n=6)、96.45%~100.10%(RSD=1.47%,n=6)、96.16%~101.10%(RSD=1.69%,n=6)。结论:该方法操作简便,精密度、稳定性、重复性好,可用于舒肝宁注射液中5种成分含量的同时测定。
ABSTRACT: OBJECTIVE: To develop a method for the simultaneous determination of 5 components in Shuganning injections. METHODS: HPLC method was adopted. The determination was performed on Symmetry® C18 column with mobile phase consisted of methanol-0.4% phosphoric acid (gradient elution) at the flow rate of 1.0 mL/min. The detection wavlengths were set at 238 nm (geniposide, baicalin) and 327 nm (chlorogenic acid, baicalein, scutellarin). The column temperature was 30 ℃ and the sample size was 10 μL. RESULTS: The linear ranges were 0.406 2-26.0 μg/mL for chlorogenic acid (r=0.999 9), 2.500 0-160.0 μg/mL for geniposide (r=0.999 9), 6.562 0-420.0 μg/mL for baicalin (r=0.999 9), 0.312 5-20.0 μg/mL for baicalein (r=0.999 6), 0.585 9-37.5 μg/mL for scutellarin (r=0.999 8). The limits of quantify were no higher than 31.20 ng,limits of detection were no higher than 15.60 ng. RSDs of precision, stability and reproducibility tests were lower than 2.0%;the recoveries were 97.72%-101.10%(RSD=1.21%,n=6),97.67%-102.40%(RSD=1.87%,n=6),97.64%-101.10%(RSD=1.31%,n=6), 96.45%-100.10%(RSD=1.47%,n=6), 96.16%-101.10% (RSD=1.69%,n=6), respectively. CONCLUSIONS: The method is simple, precise, stable and reproducible, and can be used for simultaneous determination of 5 components in Shuganning injection.
期刊: 2017年第28卷第33期
作者: 支旭然,王觅,宋浩静,董占军
AUTHORS: ZHI Xuran,WANG Mi,SONG Haojing,DONG Zhanjun
关键字: 高效液相色谱法;舒肝宁注射液;绿原酸;栀子苷;黄芩苷;黄芩素;野黄芩苷;含量
KEYWORDS: HPLC; Shuganning injections; Chlorogenic acid; Geniposide; Baicalin; Baicalein; Scutellarin; Content
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