高效液相色谱荧光法测定加替沙星注射液的含量(英文)

Analysis of gatifloxacin injection by HPLC with fluorescence detection

目的 建立高效液相色谱荧光法测定加替沙星注射液的含量方法。方法 CLC ODS柱 (15mm× 6.0mm ,5 μm ) ,流动相 :0 .0 5mol/L枸橼酸 乙腈 (80∶2 0 ) ,三乙胺调 pH3 .0 ,流速 1mL·min-1,Ex =3 60nm ,Em =465nm ,样品稀释 10 0 0倍 ,进样10 μL。 结果 加替沙星在 4～ 3 2ng范围内线性关系良好 ,回收率 (99.98± 0 .0 6) % ,日内、日间RSD <2 %。 结论 该法简便、快速、准确 ,可用于测定加替沙星注射液的含量。

OBJECTIVE To develop an HPLC method with fluorescence detection for analysis of gatifloxacin(GTX) injection.METHOD The HPLC system consisted of CLC ODS column(15cm×6.0mm, 5μm)and a RF 10AXL fluorescence detector. The mobile phase used composed of 0.05mol·L -1 citric acid acetonitrile (80∶20, v/v), adjusted pH to 3.0 with triethylamine, and the flow rate was set at 1mL·min -1 . The fluorescence detector was set at λex=360nm and λem=465 nm. GTX injection was diluted 1000 times with water, then 10μL was injected into HPLC System. RESULTS The method was linear at the GTX range from 4.0 ng to 32.0ng, the recovery of the method was (99.98±0.06)%( n =5), and the RSD was <2% for precision of intra day and between day.CONCLUSIONS The method is simple, rapid and accurate, can be used for determination of GTX.