HPLC法测定注射用阿洛西林钠舒巴坦钠中的有关物质

Related substances of azlocillin sodium and sulbactam sodium for injection by HPLC

目的利用HPLC法测定注射用阿洛西林钠舒巴坦钠中的有关物质。方法采用Hypersil C18（250 mm×4.6 mm,5μm）为色谱柱,以水-乙腈-磷酸盐缓冲液（pH值5.8）（体积比30∶30∶100）为流动相,流速为1.0 mL·min^-1,检测波长为210 nm。结果在该色谱条件下,阿洛西林与舒巴坦分离良好,阿洛西林钠有关物质测定中阿洛西林钠的质量浓度在0.408～20.4 mg·L^-1内线性关系良好,r=0.999 0,舒巴坦钠有关物质测定中舒巴坦钠的质量浓度在1.132～22.64 mg·L^-1内线性关系良好,r=0.999 9;阿洛西林钠最低检出限为81.2μg·L-1,舒巴坦钠最低检出限为0.566 mg·L-1;阿洛西林钠最低定量限为0.406 mg·L^-1,舒巴坦钠最低定量限为1.132 mg·L^-1。结论该方法简便、灵敏、准确可靠,可有效测定注射用阿洛西林钠舒巴坦钠中的有关物质。

Objective To determine the related substances of azlocillin sodium and sulbactam sodium for in- jection by HPLC. Methods a Hypersil C18 column（250 mm ×4.6 mm,5 μm） was used in the HPLC sys- tem;water-acetonitrile-phosphate buffer solution（ pH 5.8 ） （potassium dihydrogen phosphate 8.34 g and di- potassium hydrogen phosphate 0. 87 g was dissolved and diluted to 1 000 mL with water） （ V： V： V = 30： 30： 100）was selected as mobile phase;the flow rate was 1.0 mL·min^-1, the detection wavelength was set at 210 nm. Results Good separation for azlocillin and sulbactam was obtained. Good linear relationships were observed in the concentration ranges of 0. 408- 20. 4 mg· L ^-1 （ r = 0. 999 0） and 1. 132 - 22.64 mg·L ^- 1 （ r = 0. 999 9 ）, for azlocillin sodium and sulbactam sodium, respectively. The limit of detection of azolcillin sodi- um was 81.2 μg·L ^- 1 and that of sulbactam was 0. 566 mg· L ^- 1. The limits of quantification of azolcillin so- dium and sulbactam sodium were 0. 406 mg·L^- 1 and 1. 132 mg·L^- 1 ,respectively. Conclusions The method is simple, sensitive, and accurate, which can effectively determine the related substances of azlocillin sodium and sulbactam sodium for injection.