微柱高效液相色谱法测定β-甲基地高辛片和地高辛片中的强心苷。

Micro high-performance liquid chromatographic determination of cardiac glycosides in beta-methyldigoxin and digoxin tablets.

作者信息

Fujii Y, Ikeda Y, Yamazaki M

机构信息

School of Pharmacy, Hokuriku University, Kanazawa, Japan.

出版信息

J Chromatogr. 1988 Aug 31;448(1):157-64. doi: 10.1016/s0021-9673(01)84574-x.

DOI:10.1016/s0021-9673(01)84574-x

PMID:3225296

Abstract

A micro high-performance liquid chromatographic (micro-HPLC) method has been developed for the assay of beta-methyldigoxin and digoxin tablets. Quantitation of cardiac glycosides in tablets was carried out by the incorporation of dexamethasone as an internal standard. The procedure consisted of disintegration of tablets, extraction with acetone-ethanol (9:1) and injection for micro-HPLC on an ODS micro column, using acetonitrile-water (28:72) for beta-methyldigoxin tablets and methanol-water (1:1) for digoxin tablets; the effluent was monitored by UV detection at 220 nm. The average values of the contents in beta-methyldigoxin and digoxin tablets were 99.6 and 100.2% of the labelled amounts, respectively. The proposed method is sufficiently precise and sensitive to examine the content uniformity of tablets.

摘要

已开发出一种用于测定β-甲基地高辛片和地高辛片的微型高效液相色谱（micro-HPLC）方法。通过加入地塞米松作为内标物对片剂中的强心苷进行定量。该方法包括片剂崩解、用丙酮-乙醇（9:1）萃取以及在ODS微型柱上进行微型HPLC进样，β-甲基地高辛片使用乙腈-水（28:72），地高辛片使用甲醇-水（1:1）；流出物通过在220nm处的紫外检测进行监测。β-甲基地高辛片和地高辛片的含量平均值分别为标示量的99.6%和100.2%。所提出的方法足够精确和灵敏，可用于检查片剂的含量均匀度。