不同工艺条件下的桑唐饮口服液HPLC图谱比较

HPLC Analysis of Sangtangyin Oral Solution under Different Process Conditions

采用HPLC图谱分析比较方法,探讨桑唐饮口服液不同工艺对特征峰的影响。色谱柱为EclipseXDB-C18;流动相为甲醇-1%醋酸(梯度洗脱);检测波长为254nm;流速为1mL·min-1;柱温为38℃。结果表明,两种不同工艺生产的桑唐饮口服液HPLC图谱中共标示出26个共有峰;不同生产工艺对特征峰的相对含量有轻微影响,但未产生明显的新特征峰,样品2的质量稍优于样品1。该方法准确可靠,重现性好,为桑唐饮口服液的生产工艺研究提供了一定参考。

A method for monitoring Sangtangyin oral solution under different process conditions by HPLC was established and the influence of process variables on fingerprint peaks of Sangtangyin oral solution was studied. Samples was analyzed by HPLC with Eclipse XDB C18 as chromatogram column and methanol -1% acetic acid （gradient elufion ）as a mobile phase at 254nm.The flow rate and column temperature were lmL.minl and 38℃, respectively. 26 Kinds of common peaks were found in the two samples at different process conditions. The adopted process conditions showed a little influence on characteristic peaks of the samples. The quality of sample 2# was a little better than that of sample 1#. The method was reliable, accurate and provided a reference for the further study of Sangtangyin oral solution.