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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 in azlocillin sodium and sulbactam sodium for injection by HPLC. Methods The column was Hypersil C18 (250 mm × 4.6 mm, 5 μm) and the mobile phase consisted of water - acetonitrile - phosphate buffer (pH 5.8) (volume ratio 30:30:100) at a flow rate of 1.0 mL · min -1, the detection wavelength is 210 nm. Results Under the chromatographic conditions, the separation of azlocillin and sulbactam was good. The concentration of azlocillin sodium was 0.408 ~ 20.4 mg · L-1, with a good linear relationship (r = 0.999 0) , Sulbactam sodium related substances determination of sulbactam sodium concentration in the 1.132 ~ 22.64 mg · L-1 within a good linear relationship, r = 0.999 9; the minimum detectable azlocillin sodium was 81.2μg · L-1 , The minimum detectable limit of sulbactam sodium was 0.566 mg · L-1, the lowest limit of quantification of azlocillin sodium was 0.406 mg · L-1, and the lowest limit of quantification of sulbactam sodium was 1.132 mg · L-1. Conclusion The method is simple, sensitive, accurate and reliable, which can effectively determine the related substances in the azlocillin sodium and sulbactam sodium for injection.