HPLC法测定健康人体血浆中左氧氟沙星浓度*

Determination of levofloxacin in healthy human plasma by high performance liquid chromatography (HPLC) method

关键词:  HPLC  左氧氟沙星  血药浓度

Key words:  HPLC  Levofloxacin  drug concentration in plasma

摘要:

[目的]建立测定人体血浆中左氧氟沙星的高效液相色谱(HPLC)法,并用于测定20名健康受试者单次口服200mg盐酸左氧氟沙星片后24h内血药浓度。[方法]血浆样品中加入内标替硝唑后用氯仿萃取,取氯仿层后用0.01mol/L盐酸溶液反萃取,取酸水层进样。[结果]血浆中无内源性物质干扰样品测定,血药浓度线性范围为0.025～6.0mg/L(r=0.9995),最低定量限为0.025mg/L,平均提取回收率大于93.2%,批内和批间精密度峰面积(RSD)均小于6.4%,准确度在89.7%～103.1%之间。[结论]本法专属性强,操作简便,结果准确,灵敏度高,适宜于血浆中左氧氟沙星浓度的测定。

Abstract:

[Objective] To establish a HPLC method for the determ ination of Levofloxacin in human plasma and to determine the concentration of Levofloxacin in hum an plasma after oral taking a single dose 200 mg of Levofloxacin tablet in 20 healthy volunteers.[Methods] Plasma sample was added with internal standard Tinidazole and extracted with chloroform.After taking outthe layerofthe chloroform it was extracted with 0.01 mol/L hydrochloric acid repeatedly and the acid solution wasinjected into the H PLC instrum entfordeterm ination.[Results] There was no internal substance in plasma,which interfered with the determination of the samples.The linear range of medicine-containing blood was between 0.025～6.0 mg/L (r=0.999 5),the lowest quantified limit was 0.025 mg/L.The average recovery of extract was more than 93.2%.All the RSD of precision of intra or inter-batch was less than 6.4% and the accuracy was between 89.7%～103.1%.[Conclusions] The method has a good specificity,can be manipulated conveniently.The obtained result is correct with high sensitivity.So it is a suitable method for the determination of Levofloxacin.