【摘要】：為建立一種藥物伊班膦酸鈉注射液主成分-伊班膦酸的離子色譜分析方法,采用Ion Pac AS18陰離子交換色譜柱,利用在線淋洗液發(fā)生器自動(dòng)產(chǎn)生氫氧化鉀梯度淋洗液(12~70 mmol·L~(-1),時(shí)間程序?yàn)?7 min),并使用自動(dòng)再生抑制型電導(dǎo)檢測(cè)。結(jié)果表明,伊班膦酸濃度在0~75.25?g·m L~(-1)范圍內(nèi),線性相關(guān)系數(shù)R2=0.9995,呈現(xiàn)顯著的線性相關(guān)關(guān)系;供試液重復(fù)進(jìn)樣5次,峰面積RSD為0.21%,保留時(shí)間RSD為0.01%,理論板數(shù)均大于50 000,方法系統(tǒng)適用性良好;5份供試樣品溶液伊班膦酸含量的RSD值為0.80%,小于等于2.0%,方法重復(fù)性良好;供試樣品3個(gè)濃度水平的回收率均在99%~101%之間,加標(biāo)回收率試驗(yàn)的RSD均小于1.00%,符合藥品規(guī)定要求。該方法穩(wěn)定、重復(fù)性好且回收率高,可滿足伊班膦酸鈉注射液中主成分含量的測(cè)定要求。
[Abstract]:In order to establish an ion chromatographic method for the determination of ibandronic acid in ibandronate sodium injection, a Ion Pac AS18 anion exchange column was used. The gradient leaching solution of potassium hydroxide (1270 mmol L-1) was automatically generated by the on-line eluent generator. The time program was 17 min), and automatic regenerative inhibition conductance detection was used. The results showed that the linear correlation coefficient R _ 2 ~ (2 +) was 0.9995 in the range of 0 ~ 75.25 g mL ~ (-1) for ibandronic acid, and there was a significant linear correlation between the concentration of ibandronic acid and the concentration of ibandronic acid in the range of 0 ~ 75.25g mL ~ (-1). The peak area RSD is 0.21, the retention time RSD is 0.01, the number of theoretical plates is more than 50000, the applicability of the method system is good, the RSD value of Ibanphosphonic acid content in 5 samples is 0.80, less than 2.0, and the method has good repeatability. The recoveries of the three concentration levels of the tested samples were between 99 and 101%, and the RSD of the standard added recovery test was less than 1.00, which met the requirements of the drug regulations. The method is stable, reproducible and high recovery. It can be used to determine the content of principal components in ibandronate sodium injection.
【作者單位】： 安徽農(nóng)業(yè)大學(xué)茶與食品科技學(xué)院;安徽農(nóng)業(yè)大學(xué)生物技術(shù)中心;兆科藥業(yè)(合肥)有限公司;
【基金】：安徽省自然科學(xué)基金面上項(xiàng)目(1608085MC54) 安徽省高校自然科學(xué)科學(xué)研究項(xiàng)目重點(diǎn)項(xiàng)目(KJ2015A060) 安徽農(nóng)業(yè)大學(xué)青年科學(xué)基金重點(diǎn)項(xiàng)目(2014zr009),安徽農(nóng)業(yè)大學(xué)引進(jìn)與穩(wěn)定人才基金項(xiàng)目(yj2015-19)共同資助
【分類號(hào)】：O657.75;R927.2

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