高效液相色谱法测定杀菌止痒洗剂的稳定性

Determination of Stability of Shajunzhiyang Lotion by HPLC

目的：建立杀菌止痒洗剂中苦参碱含量的高效液相色谱（HPLC）测定方法,并用此方法对杀菌止痒洗剂进行稳定性考察.方法：采用Diamonsil-C18色谱柱,流动相为乙腈-水-三乙胺（97∶3∶0.2,PH3.5）、检测波长207nm、流速1.0 mL/min、柱温为25℃,稳定性研究采用加速试验和长期试验.结果：苦参碱在0.081 88～32.752 0μg时与峰面积呈良好的线性关系（r=0.999 9）,平均加样回收率为99.2％,RSD =0.69％;杀菌止痒洗剂经过6个月加速实验和12个月长期实验,苦参碱含量无明显变化.结论：所建立的HPLC方法能很好地分离、检测杀菌止痒洗剂中苦参碱,并能评价杀菌止痒洗剂的稳定性.

Objective： To establish HPLC method for determination of matrine in Shajunzhiyang lotion, and determine the stability of the sample. Methods： The HPLC method was carried out on Diamonsil-Cls column using acetonitrile-water-triethylamine （ adjust the pH to 3.5 by phosphoric acid ） as mobile phase, and the detection wavelength was 207 nm, the flow rate was 1.0 mL/min and the temperature of column was 25℃. The stability of Shajunzhiyang lotion was studied with accelerated test and long-term test. Results： In the results by HPLC method the calibration curve for matrine was linear in the range of 0.081 88 ~ 32.752 0 μg （ r = 0.999 9） . The average recovery was 99.2% , RSD was 0. 69% （n=6）. No after 6-month accelerated test significant change of matrine content was found in Shajunzhiyang lotion and 12-month long-term test. venient, precise and reliable for determination of matrine in the lotion is good. Conclusion： This HPLC method is conShajunzhiyang lotion, and the stability of