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目的:建立复方体外培育牛黄凝胶制剂中胆红素、丹皮酚和盐酸小檗碱含量的HPLC法。方法:采用依利特ODSBPC_(18)(200 mm×4.6 mm,5μm)色谱柱,胆红素测定流动相为乙腈(A)-水(B)(95∶5),检测波长:450 nm;丹皮酚和盐酸小檗碱测定流动相为乙腈(A)-0.1%磷酸(B)梯度洗脱,检测波长为265 nm,流速为1.0 ml·min~(-1),柱温为30℃。结果:胆红素在0.215 6~1.293 6μg范围内线性关系良好(r=0.999 6),平均加样回收率为98.25%,RSD为0.62%(n=6),丹皮酚在0.207 2~2.072 0μg范围内线性关系良好(r=1.000 0),平均加样回收率为96.7%,RSD为1.17%(n=6),盐酸小檗碱在0.206 8~2.068 0μg范围内线性关系良好(r=0.995 2),平均加样回收率为97.58%,RSD为0.77%(n=6)。结论:本试验所建立的方法简单可行,准确性、重复性好,可以作为复方体外培育牛黄凝胶制剂的质量控制方法。
OBJECTIVE: To establish HPLC method for the determination of bilirubin, paeonol and berberine hydrochloride in the compound bovine gel preparation. Methods: Ellite ODSBPC_ (18) (200 mm × 4.6 mm, 5 μm) was used for the determination of bilirubin. The mobile phase was acetonitrile (A) -water (B) Phenol and berberine hydrochloride were eluted with a gradient of acetonitrile (A) - 0.1% phosphoric acid (B) at a detection wavelength of 265 nm at a flow rate of 1.0 ml · min -1 and a column temperature of 30 ° C. Results: The bilirubin showed a good linearity (r = 0.999 6) within the range of 0.215 6-1.293 6 μg with an average recovery of 98.25% and a RSD of 0.62% (n = 6) and paeonol 0.207 2 ~ 2.072 (R = 1.000 0). The average recovery was 96.7% and the RSD was 1.17% (n = 6). There was a good linear relationship between berberine hydrochloride and 0.206 8 ~ 2.068 0 μg (r = 0.995 2). The average recovery was 97.58% with RSD of 0.77% (n = 6). Conclusion: The method established in this study is simple, feasible, accurate and reproducible. It can be used as a quality control method for compound in vitro bovine gel preparation.