硫酸阿托品注射液有关物质和pH值的相关性分析  

Correlation Analysis of Related Substance and pH of Atropine Sulfate Injection

作　　者：陈希 张文婷 

机构地区：[1]江西省药品检验检测研究院,江西南昌330029

出　　处：《今日药学》2016年第2期112-114,共3页Pharmacy Today

摘　　要：目的建立硫酸阿托品注射液有关物质新的测定方法,并研究有关物质和pH值之间的相关性。方法有关物质HPLC方法：Xbridge C_（18）柱（4.6 mm×250 mm,5μm）;流动相A：庚烷磺酸钠磷酸盐溶液（含0.05 mol/L磷酸二氢钾溶液和0.002 5 mol/L庚烷磺酸钠溶液,用磷酸调节pH至3.9）,流动相B：乙腈,梯度洗脱;流速：1 mL/min;检测波长210 nm,进样量为20μL。结果总杂质量与pH值大小成正相关。样品pH值在3.8~4.5间,总杂质量≥3.0%的占0.8%;在4.5~5.5间,总杂质量≥3.0%的有15.6%。结论杂质增大的主要原因为pH值的增大导致硫酸阿托品水解速度增加。pH值上限控制为4.5,可以提高合格率。OBJECTIVE To establish suitable method for the determination of related substances in atropine sulfate injection.To conduct a correlation study on the related substances and p H.METHODS HPLC method was applied with chromatographic conditions as follows： Xbridge C_（18） column（4.6 mm×250 mm,5 μm）; mobile phase A： solution of sodium heptanesulfonate phosphate（ including0.05 mol/L solution of potassium dihydrogen phosphate and solution of 0.002 5 mol/L sodium heptanesulfonate,pH value was adjusted to 3.9 with phosphoric acid）,mobile phase B： acetonitrile（ gradient elution）.The flow rate was 1.0 mL/min.Detection wavelength was210 nm,and sample size was 20 μL.RESULTS There was positive correlation of total impurity quantity and pH value.When pH value was between 3.8-4.5,there were 0.8% samples which total impurity was more than 3%.When pH value was between 4.5-5.5,there were 15.6% samples which total impurity was more than 3%.CONCLUSION The main reason for the increase of impurities is the increased pH value which can lead to increased hydrolysis of atropine sulfate rate.Qualified rate can be improved when the upper limit of pH value is 4.5.

关 键 词：硫酸阿托品注射液 有关物质 PH 

分 类 号：R97[医药卫生—药品]