摘要
目的建立分离测定他达拉非及其产品的反相高效液相色谱法。方法以Dionex Kromasil ODS1柱(250 mm×4.6 mm,5μm)为色谱柱,流动相为甲醇-乙腈-用三乙胺调节pH值至3.0的0.05 mol/L磷酸溶液(44:13:43),流速为1.5 mL/min,检测波长为290 nm,进样量20μL。结果他达拉非线性浓度范围为11.2-86.7μg/mL,r=0.999 9(n=6),平均回收率为100.20%,RSD为0.58%(n=6),重复进样RSD为0.38%(n=5),检出限为0.9 ng(S/N=3)。结论该法简便、快速、准确,适用于测定他达拉非及其产品的含量。
Objective To develop a RP- HPLC method for the isolation and determination of tadalafil and its products. Methods Chromato- graphic conditions included: a column of Dionex Kromasil ODS1 (250 mm ×4. 6 mm,5μm), a mobile phase was a mixture of methanol, acetonitrile, 0.05 mol/L phosphoric acid (adjust with triethylamine to a pH of 3.0)(44:13:43), the flow rate was 1.50 mL/min,the detection wavelengths was at 290 nm. Results There was a good linear relationship over the range of 11.2-86. 7 μg/mL, r =0. 999 9(n = 6).The average recovery 100.20% with RSD was 0.58% (n=6).The RSD for repetition was 0.38% (n=5).The detection limit is 0.9 ng(S/N=3). Conclusion The method was simple, rapid, accurate and can be used to assay tadalafil and its products.
出处
《中国药业》
CAS
2006年第15期34-35,共2页
China Pharmaceuticals