HPLC法测定氟康唑注射液中有关物质及含量

目的：考察浮小麦中的农药残留量、重金属及有害元素，建立测定浮小麦中棉籽糖及葡萄糖的HPLC法。方法：参照《中国药典》2010年版一部附录方法检测浮小麦中的农药残留量、重金属及有害元素。选用PhenomenexLunaNH，柱，以乙腈-水（70：30）为流动相，流量为1．0mL·min-1，柱温为30℃，采用示差折光检测器，检测池温度为40℃，测定两种糖的含量。结果：药材中含有有机氯类农药残留量和铅、镉、砷、汞、铜等重金属及有害元素的量较低。棉籽糖在2．35-46．92Ug范围内线性关系良好，平均回收率101．0％（RSD=2．0％）；葡萄糖在12．30—123．02μg范围内线性关系良好，平均回收率98．8％（RSD=1．6％）。结论：所建含量测定方法简便、准确、耐用性好，为确保药材质量和指导临床用药提供了参考依据。

Determination of Fluconazole Injection and its Related Substances by HPLC

To investigate the pesticide residues,heavy metals and harmful elements, and establish an HPLC method for the determinations of cottonseed sugar and glucose of Fructus Tritici Levis. Methods： Pesticide residues, heavy metals and harmful ele ments were investigated according to Chinese Pharmacopoeia 2010 Edition Volume I Appendix. The contents of cottonseed sugar and glucose were determined by HPLC method which were equipped with a NH2 column, acetonitrile-water（70： 30）as the mobile phase at the flow rate of 1.0 mL . min- 1, the column temperature was 30 ℃ ; RID was used and the detection pool temperature was 40 ℃. Re sults： The contents of several organochlorine pesticide residues and Pb, Cr, As, Hg, Cu and other heavy metals and harmful elements were lower. The linearity of cottonseed sugar was obtained in the range of 2. 35-46. 92 Ixg,the average recovery was 101.0% （ RSD = 2. 0% ） ; the lineafity of glucose in the range of 12. 30-123.02 Ug, the average recovery was 98.8% （ RSD = 1.6% ）. Conclusion ： The established methods are simple and accurate, and can be applied to ensure the quality of medicines and provide the basis for the clini cal medication.