【摘要】：目的:改進(jìn)高效液相色譜法測定阿那曲唑原料藥中的有關(guān)物質(zhì)。方法:色譜柱為Welch Materials XB C_(18),改進(jìn)后的流動相為乙腈-水(35∶65,V/V),流速為1.0 m L/min,檢測波長為210 nm,柱溫為25℃,進(jìn)樣量為20μL。結(jié)果:阿那曲唑原料藥中僅檢測出1個(gè)雜質(zhì)(雜質(zhì)A),檢測質(zhì)量濃度線性范圍為0.1~1.6μg/m L(r=0.999 6);定量限為0.1μg/m L,檢測限為0.02μg/m L;精密度、穩(wěn)定性、重復(fù)性試驗(yàn)的RSD2.0%;加樣回收率為98.95%~105.29%(RSD=1.78%,n=9)。結(jié)論:改進(jìn)后的方法操作簡便、結(jié)果準(zhǔn)確,可用于測定阿那曲唑原料藥中的有關(guān)物質(zhì)。
[Abstract]:Objective: to improve the HPLC method for the determination of related substances in Anatrizole. Methods: the chromatographic column was Welch Materials XB C18, the improved mobile phase was acetonitrile-water (35: 65 V / V), the flow rate was 1.0 mL / min, the detection wavelength was 210 nm, the column temperature was 25 鈩，

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