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目的建立HPLC法测定盐酸纳洛酮注射液有关物质方法。方法采用十八烷基硅烷键合硅胶为填充剂的色谱柱,流动相为乙腈-水(每580 m L含辛烷磺酸钠1.36 g、氯化钠1.0 g、磷酸1 m L)(体积比20∶80),流速为1.0 m L·min~(-1),检测波长为230 nm,柱温为40℃,进样量为10μL,测定盐酸纳洛酮注射液杂质I和总杂质的含量。结果杂质I在质量浓度0.230 0~46.008 9 mg·L~(-1)内与峰面积呈良好线性关系(r=0.999 9),平均回收率(n=9)为98.11%,RSD为1.42%,重复性试验主峰面积RSD为0.08%,样品中杂质I峰面积RSD为0.21%,样品中其他杂质总峰面积RSD为1.43%。结论该法可用于盐酸纳洛酮注射液的有关物质的含量测定。
Objective To establish a HPLC method for the determination of naloxone hydrochloride injection related substances. Methods The column was octadecylsilane bonded silica as mobile phase. The mobile phase was acetonitrile-water (containing 1.36 g sodium octane sulfonate, 1.0 g sodium chloride and 1 mL phosphate per 580 mL) (volume Than 20:80), the flow rate was 1.0 m L · min -1, the detection wavelength was 230 nm, the column temperature was 40 ℃ and the injection volume was 10 μL. The impurity I and the total impurities of naloxone hydrochloride injection content. Results The impurity I showed a good linear relationship with the peak area (r = 0.999 9) within the mass concentration range of 0.230 0 to 46.008 9 mg · L -1, with an average recovery of 98.11% (n = 9) and a RSD of 1.42% , The main peak area RSD of repeatability test was 0.08%, the peak area RSD of impurity I in the sample was 0.21%, and the total peak area RSD of other impurities in the sample was 1.43%. Conclusion This method can be used for the determination of related substances in naloxone hydrochloride injection.