摘要
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 an HPLC method for the determination of related substances in naloxone hydrochloride injection. Methods The chromatographic separation of the related substances was performed on a C_（18） column（ 250 mm × 4. 6 mm,5 μm） with a water phase（ containing 1. 36 g Sodium octance Sulfonate,1. 0 g sodium chloride and 1 mL phosphate per 580 mL） and acetonitrile（ 80∶ 20） as mobile phase. The flow rate was 1. 0 mL·min^-1 and the detection wavelength was 230 nm. The column temperature was 40 ℃,and the volume of injection was 10 μL. Results The liner range of impurity I was 0. 230 0- 46. 008 9 mg·L^-1（ r = 0. 999 9） and the average recovery was 98. 11% with RSD of 1. 42%（ n = 9）,The RSD of the main peak area was 0. 08% in the repeatability test,the RSD of impurity I peak area was 0. 21%,and the RSD of the peak area of other total impurities was 1. 43%. Conclusions The established HPLC method can be used for the determination of related substances in naloxone hydrochloride injection.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2016年第10期778-782,794,共6页
Journal of Shenyang Pharmaceutical University
