HPLC-ELSD法测定大豆磷脂注射液中有关物质  

Determination of Related Substances in Soybean Phosphatidylcholine Injection by HPLC-ELSD

作　　者：蒋玲 陈亮 刘衍兴 屠锡德[3] 周建平[3] 

机构地区：[1]徐州市光合生物营养品有限公司研发部,江苏徐州221003 [2]江苏恩华药业集团有限责任公司技术中心,江苏徐州221003 [3]中国药科大学药剂学教研室,江苏南京210009

出　　处：《药学进展》2007年第8期366-369,共4页Progress in Pharmaceutical Sciences

摘　　要：目的：建立HPLC-ELSD法测定大豆磷脂注射液中有关物质溶血性磷脂酰胆碱的含量.方法：采用C18色谱柱（250 mm×4.6 mm,5 μm）,以甲醇-冰醋酸（500∶10,用三乙胺调pH至6.2）为流动相,柱温为室温,流速为1.0 mL/min,进样量为10 μL;蒸发光散射检测器参数：载气为空气,载气压力为250 kPa,载气流量为2.0 L/min,漂移管温度为60 ℃.结果：大豆磷脂注射液中主成分磷脂酰胆碱和溶血性磷脂酰胆碱能很好地分离检出,其线性浓度范围分别为20.4～801.6（r=0.999 5）和10.652～532.6（r=0.999 4）mg/L,溶血性磷脂酰胆碱的最低检测限为5.326 ng.辅料对检测无干扰.结论：该方法准确、灵敏、快捷,适用于大豆磷脂注射液中有关物质的测定.Objective： To establish a HPLC-ELSD method for the detennination of related substances（lysophosphatidylcholine,LPC） in soybean phosphatidylcholine injection. Methods： A C18 column（250 mm × 4.6 mm, 5μm）and the mobile phase of methanol-glacial acetic acid （500： 10, adjusted to pH 6.2 with triethyl- amine） were used at room temperature with a flow rate of 1.0 mUmin and a injection volume of 10μL. ELSD para-meters ： air as carrier gas, carrier gas pressure of 250 kPa, carrier gas flow rate of 2.0 L/min, and drift tube temperature of 60 ℃. Results： Main component PC and LPC in the injection could be well separated and detected. The linear concentration ranges of PC and LPC were 20.4-801.6 （ r = 0.999 5） and 10.652-532.6 （ r = 0. 999 4）mg/L respectively. The minimal detection limit of LPC was 5.326 ng. There was no influence of excipients on the determination. Conclusion： The method is accurate, sensitive, rapid and suitable for the determination of related substances in soybean phosphatidylcholine injection.

关 键 词：大豆磷脂注射液 有关物质 溶血性磷脂酰胆碱 HPLC-ELSD法 含量测定 

分 类 号：TQ460.7[化学工程—制药化工]