首页|HPLC法测定肾康灵胶囊中盐酸小檗碱的含量

HPLC法测定肾康灵胶囊中盐酸小檗碱的含量

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目的 建立肾康灵胶囊中盐酸小檗碱的HPLC含量测定方法,为质量控制提供依据.方法 采用HPLC法,色谱柱:Sapphire-C18柱(4.6×250 mm,5 μm);流动相:乙腈-0.1%磷酸溶液(梯度洗脱);流动相流速:1.0 mL·min-1;检测波长:265 nm;柱温:30 ℃,进样量:10 μL.结果 盐酸小檗碱含量在0.0584~0.5840 μg范围内与峰面积值呈良好线性关系(R2=0.9981),精密度和重复性试验的RSD均<2.0%(n=6),稳定性试验(18 h内)的RSD为1.11%,平均加样回收率为98.24%,RSD=1.43%(n=6).结论 该方法快速简便、稳定性好,专属性强,重复性良好,可为肾康灵胶囊的质量控制提供依据.
Determination of Berberine Hydrochloride in ShenKangLing Capsules by HPLC
OBJECTIVE To establish the HPLC method for determinating the content of berberine hydrochlo-ride in ShenKangLing capsules,so as to provide a basis for quality control of ShenKangLing capsules.METHODS HPLC method was adopted.The determination was performed on a Sapphire-C18 column(4.6 ×250 mm,5 µm)with a mobile phase consisted of acetonitrile-0.1%phosphoric acid solution(gradient elution)at a detection wavelength of 265 nm and a flow rate of 1.0 mL·min-1.The sample size was 10 μL.RESULTS The content of berberine hydrochloride from 0.0584 to 0.5840 μg showed a good linear relationship with peak area value(R2=0.9981),RSD for precision and repeatability test was<2.0%(n=6),RSD for stability test(within 18 hours)was 1.11%,average sample recovery was 98.24%,and RSD=1.43%(n=6).CONCLUSION This method is simple,accu-rate,strong exclusivity,good stability and reproducibility,which can provides a reference for the quality control of ShenKangLing capsules.

ShenKangLing capsulesHPLCBerberine hydrochlorideContent determination

肖淋、洪海棉、陈成辉、陈肖虹、郑小娟I

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福建中医药大学附属人民医院药学部,福建福州 350004

肾康灵胶囊 高效液相色谱 盐酸小檗碱 含量测定

福建省科技厅引导性项目

2021Y0033

2024

海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
年,卷(期):2024.36(1)
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