新疆医科大学学报
新疆醫科大學學報
신강의과대학학보
JOURNAL OF XINJIANG MEDICAL UNIVERSITY
2014年
12期
1608-1613,1618
,共7页
刘忠莹%杨鹏博%黄晓军%狄斌%陈金龙
劉忠瑩%楊鵬博%黃曉軍%狄斌%陳金龍
류충형%양붕박%황효군%적빈%진금룡
注射用头孢唑林钠%有关物质%液相色谱串联质谱法%分离%鉴别
註射用頭孢唑林鈉%有關物質%液相色譜串聯質譜法%分離%鑒彆
주사용두포서림납%유관물질%액상색보천련질보법%분리%감별
Cefazolin sodium for injection%related substances%LC-MS/MS%analysis%determination
目的:建立对注射用头孢唑林钠中有关物质进行定性分析的 LC-MS/MS 法。方法采用 Phenome-nex ODS(250 mm×4.6 mm,5μm)为色谱柱;10 mmol 醋酸铵水溶液为流动相 A,乙腈为流动相 B 的挥发性流动相线性梯度洗脱。采集有关物质的 PDA 谱、质谱母离子及子离子谱,并进行结构解析,推测有关物质的结构。结果在所建立的条件下,注射用头孢唑林钠中有关物质分离良好,检出11个有关物质峰。结论本文建立的LC-MS/MS 法可有效地分离分析注射用头孢唑啉钠中的有关物质,并为其质量控制和工艺纯化提供技术参考。
目的:建立對註射用頭孢唑林鈉中有關物質進行定性分析的 LC-MS/MS 法。方法採用 Phenome-nex ODS(250 mm×4.6 mm,5μm)為色譜柱;10 mmol 醋痠銨水溶液為流動相 A,乙腈為流動相 B 的揮髮性流動相線性梯度洗脫。採集有關物質的 PDA 譜、質譜母離子及子離子譜,併進行結構解析,推測有關物質的結構。結果在所建立的條件下,註射用頭孢唑林鈉中有關物質分離良好,檢齣11箇有關物質峰。結論本文建立的LC-MS/MS 法可有效地分離分析註射用頭孢唑啉鈉中的有關物質,併為其質量控製和工藝純化提供技術參攷。
목적:건립대주사용두포서림납중유관물질진행정성분석적 LC-MS/MS 법。방법채용 Phenome-nex ODS(250 mm×4.6 mm,5μm)위색보주;10 mmol 작산안수용액위류동상 A,을정위류동상 B 적휘발성류동상선성제도세탈。채집유관물질적 PDA 보、질보모리자급자리자보,병진행결구해석,추측유관물질적결구。결과재소건립적조건하,주사용두포서림납중유관물질분리량호,검출11개유관물질봉。결론본문건립적LC-MS/MS 법가유효지분리분석주사용두포서람납중적유관물질,병위기질량공제화공예순화제공기술삼고。
Objective To establish the identification of the related substances in Cefazolin sodium for injec-tion by LC-MS/MS method.Methods High pressure/performance liquid chromatography (HPLC)sepa-ration was carried out on Phenomenex ODS (250×4.6 mm,5 μm)with a gradient mobile phase consisting of 10 mmol/L ammonium acetate and pure acetonitrile.The PDA,parent ions and the corresponding prod-uct ions spectra of all the related substance in Cefazolin sodium for injection were determined.Results Good resolution of Cefazolin sodium and their main related substances were achieved.Eleven related sub-stances in Cefazolin sodium for injection were detected by LC-MS/MS.Conclusion The established method is effective in the separation and identification of the related substances in Cefazolin sodium for in-jection and the results are useful for its quality control.