HPLC法研究金黄膏稳定性及其质控标准.docVIP

HPLC法研究金黄膏稳定性及其质控标准 　　[摘要] 目的 探讨HPLC法测定金黄膏中小檗碱和巴马丁含量、稳定性与质控标准。 方法 通过色谱条件的优化，建立一种金黄膏测定方法，采用高效液相色谱法，色柱为：Apollo C18（250 mm×4.6 mm，5 μm），流动液相为乙腈-0.1%磷酸（二元梯度洗脱），检测波长346 nm，流速为1.0 mL/min，柱温为30℃，测定样品的精确度、准确度、稳定性、重现性及专属性特性。 结果 将金黄膏按照上述方式进行，并且根据色谱检测方式判断，盐酸小檗碱为2.04%，巴马丁为1.95%，具有较好的稳定性；盐酸小檗碱RSD为1.51%，巴马丁RSD为2.03%。巴马丁平均回收率为98.8%，RSD为1.85%，盐酸小檗碱平均回收率为100.9%，RSD为2.5%。由此说明，盐酸小檗碱和巴马丁在两种不同的药物成分在24 h内稳定性相对较好，且该检测方法具有较好的重现性。 结论 HPLC测定法分析金黄膏中小檗碱和巴马丁含量及稳定性与质控标准效果理想，该方法准确、简便，重现性好，能够为制订质控标准提供依据，值得推广应用。 　　[关键词] HPLC测定法；金黄膏；小檗碱；巴马丁；稳定性；质控标准 　　[中图分类号] R914.1 [文献标识码] A [文章编号] 1673-7210（2016）08（c）-0133-04 　　[Abstract] Objective To investigate content and stability and quality control standard assays of berberine and golden cream palmatine by HPLC determination. Methods Through the optimization of the chromatographic conditions， a golden paste determination method established， high-performance liquid chromatography was used： Apollo C18 column （250 mm×4.6 mm， 5 μm）， liquid phase was acetonitrile-0.1% phosphoric acid （binary gradient elution）. The detection wavelength was 346 nm， velocity of flow was 1.0 mL/min. The column temperature was 30℃， determination of accuracy， accuracy， stability and reproducibility and specificity characteristics were detected. Results The golden cream was conducted in accordance with the above-described manner and judged in accordance with chromatographic detection mode， berberine was 2.04%， palmatine was 1.95%， with good stability； berberine hydrochloride RSD was 1.51%， palmatine RSD was 2.03%. Average palmatine recovery was 98.8%， RSD was 1.85%， hydrochloric small firewood average recovery was 100.9%， RSD was 2.5%. It showed that berberine palmatine stability in two different pharmaceutical ingredient within 24 h was relatively good， and the detection method had good reproducibility. Conclusion HPLC assay analysis of golden cream and palmatine content and stability and quality control standard of berberine is satisfactory， this method is accurate， simple， repro