高效液相色谱法测定药物剂型中的色甘酸钠

HPLC determination of sodium cromoglycate in pharmaceutical dosage forms.

作者信息

Radulović D, Kocić-Pesić V, Pećanac D, Zivanović L

机构信息

Departiment of Pharmaceutical Chemistry, Faculty of Pharmacy, Belgrade, Yugoslavia.

出版信息

Farmaco. 1994 May;49(5):375-6.

PMID:8080622

Abstract

A reversed-phase high-performance liquid chromatography (HPLC) method is described for the determination of sodium chromoglycate (SCG) in bulk drug and pharmaceutical dosage forms (capsules, solutions, gels). Aliquots were chromatographed on C18 columns using methanol: phosphate buffer (50:50 v/v) at pH 2.3 as the mobile phase. Detection was performed at 326 nm with a linear range of 0.05-0.5 microgram/ml (r = 0.9999). Recovery values ranged from 99.21 to 106.31% (N = 9). The proposed method is rapid and simple, free from interference by excipient and degradation products, and can be recommended for routine control analysis of sodium chromoglycate commercial products and magistral formulations.

摘要

描述了一种反相高效液相色谱（HPLC）法，用于测定原料药及药物剂型（胶囊、溶液、凝胶）中的色甘酸钠（SCG）。取等分试样在C18柱上进行色谱分析，以甲醇：磷酸盐缓冲液（50:50 v/v），pH 2.3作为流动相。在326 nm处进行检测，线性范围为0.05 - 0.5微克/毫升（r = 0.9999）。回收率值在99.21%至106.31%之间（N = 9）。所提出的方法快速简便，不受辅料和降解产物的干扰，可推荐用于色甘酸钠商业产品和普通制剂的常规控制分析。