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1、學(xué)報(bào)462JournalofChinaPharmaceuticalUniversity2010,41(5):462-466用加校正因子的主成分自身對(duì)照法測(cè)定注射用前列地爾中有關(guān)物質(zhì)的含量*丁銳,紀(jì)宏,陳思,劉奕明,余立(北京市藥品檢驗(yàn)所,北京100035)摘要建立用加校正因子的主成分自身對(duì)照法測(cè)定注射用前列地爾中有關(guān)物質(zhì)的含量。采用C18色譜柱(250mm46mm,5m),以0007mol/L磷酸鹽緩沖液(pH650)乙腈甲醇(70255)為流動(dòng)相,流速為15mL/min,柱溫為30!,檢測(cè)波
2、長(zhǎng)為196nm,進(jìn)樣量為20L。測(cè)定前列腺素A1、前列腺素B1相對(duì)于前列地爾的相對(duì)保留時(shí)間及校正因子,并計(jì)算其含量;前列地爾、前列腺素A1、前列腺素B1的質(zhì)量濃度在0125~500g/mL范圍內(nèi)線性關(guān)系良好,r均達(dá)到0999,雜質(zhì)前列腺素A1和前列腺素B1相對(duì)于主成分前列地爾的相對(duì)保留時(shí)間分別為270和287,校正因子分別為2296和1681。本方法操作簡(jiǎn)便,結(jié)果準(zhǔn)確可靠,無(wú)需提供雜質(zhì)對(duì)照品,能夠準(zhǔn)確測(cè)定注射用前列地爾的有關(guān)物質(zhì)。關(guān)鍵詞前列地爾;前列腺素A1;前列腺素B1;校正因子中圖分類號(hào)TQ460
3、72文獻(xiàn)標(biāo)識(shí)碼A文章編號(hào)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
