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作 者:费昊[1] 崔锋[1] 唐飞[1] 沙薇 张庆文[1]
机构地区:[1]中国医药工业研究总院上海医药工业研究院,创新药物与制药工艺国家重点实验室,上海201203 [2]河南泰丰制药有限公司,河南郑州452392
出 处:《中国医药工业杂志》2016年第6期783-785,共3页Chinese Journal of Pharmaceuticals
摘 要:建立了核磁共振定量法(QNMR)测定骨化三醇的含量。以马来酸为内标,氘代丙酮为溶剂,以NMR谱测定骨化三醇,并与美国药典38版收载的HPLC法(外标法)比较,测定结果基本一致。本研究建立的核磁定量方法准确、快速,不需要对照品,可为同类药物的含量测定提供参考。A quantitative nuclear magnetic resonance (QNMR) method was established for the determination of calcitriol. NMR spectra were obtained in (CD3) 2CO, with maleic acid as the internal standard. The result was in compared with that obtained by HPLC external standard method which was recorded in USP 38. It showed that there was no significant difference between these two methods. A rapid and accurate QNMR method without reference standard material was established for the quantitative determination of calcitriol, which could be a reference to such kind of drug substance.
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