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1、学报462JournalofChinaPharmaceuticalUniversity2010,41(5):462-466用加校正因子的主成分自身对照法测定注射用前列地尔中有关物质的含量*丁锐,纪宏,陈思,刘奕明,余立(北京市药品检验所,北京100035)摘要建立用加校正因子的主成分自身对照法测定注射用前列地尔中有关物质的含量。采用C18色谱柱(250mm46mm,5m),以0007mol/L磷酸盐缓冲液(pH650)乙腈甲醇(70255)为流动相,流速为15mL/min,柱温为30!,检测波
2、长为196nm,进样量为20L。测定前列腺素A1、前列腺素B1相对于前列地尔的相对保留时间及校正因子,并计算其含量;前列地尔、前列腺素A1、前列腺素B1的质量浓度在0125~500g/mL范围内线性关系良好,r均达到0999,杂质前列腺素A1和前列腺素B1相对于主成分前列地尔的相对保留时间分别为270和287,校正因子分别为2296和1681。本方法操作简便,结果准确可靠,无需提供杂质对照品,能够准确测定注射用前列地尔的有关物质。关键词前列地尔;前列腺素A1;前列腺素B1;校正因子中图分类号TQ460
3、72文献标识码A文章编号1000-5048(2010)05-0462-05Assayoftherelatedsubstancesinalprostadilforinjectionwiththecorrectionfactor*DINGRu,iJIHong,CHENS,iLIUYiming,YULiBeijingInstituteforDrugControl,Beijing100035,ChinaAbstractToestablishamethodusingthecorrectionfactorforthe
4、determinationoftherelatedsubstanceinalprostadilforinjectionTheassaywascarriedoutonaC18column(250mm46mm,5m)withthemobilephaseof0007mol/Lphosphatebuffersolution(pH6.50)acetonitrilemethanol(70255)ataflowrateof15mL/min.Thecolumntemperature,thedetectionwaveleng
5、thandtheinjectionvolumeweresetat30∀C,196nm,and20L,respectivelyTherelativeretentiontimeandthecorrectionfactorbetweenprostaglandinA1andalprostadi,lprostaglandinB1andalprostadilweredeterminedTherelativeretentiontimewasusedtodeterminethepositionofprostaglandinA1and
6、prostaglandinB1,thecorrectionfactorwasusedtodeterminethecontentofprostaglandinA1andprostaglandinB1impuritiesinalprostadilGoodlinearrelationshipsofalprostadi,lprostaglandinA1andprostaglandinB1wereobtainedovertheconcentrationrangeof0125500g/mL(r=0999).Therela
7、tiveretentiontimebetweenprostaglandinA1andalprostadilwas270,therelativeretentiontimebetweenprostaglandinA1andalprostadilwas287;thecorrectionfactorbetweenprostaglandinA1andalprostadilwas2296;thecorrectionfactorbetweenprostaglandinB1andalprostadilwas1681Thismet
8、hodwasprovedtobesimple,accurateandreliabletodeterminetherelatedsubstanceofalprostadilforinjectionwithoutstandardsubstancesofprostaglandinA1andprostaglan
