Determination of Clodronate Disodium and Its Related Substances in Its Preparations by Ion Chromatography
- VernacularTitle:离子色谱法测定氯膦酸二钠及其制剂的含量和有关物质
- Author:
Yi LEI
;
Xinlin ZHONG
- Publication Type:Journal Article
- Keywords:
Ion chromatography;
clodronate disodium
- From:
Chinese Journal of Analytical Chemistry
2009;37(7):1065-1068
- CountryChina
- Language:Chinese
-
Abstract:
A new ion chromatography was developed for the determination of clodronate disodium and its related substances. A suppressed conductivity detection was used. The analytical column was an IonPac AS11-HC anion-exchange column. The column temperature was maintained at 30 ℃. The potassium hydroxide solution was used as the eluent at a flow rate of 1.2 mL/min. For the determination of content and related substances,an isocratic elution program and a gradient elution program were performed, respectively.A good linear relationship was observed in the concentration range of clodronate disodium of 0.0568-0.1895 g/L(r=0.9999). The average recoveries of the injection and the capsules were 100.1%(RSD=0.7%) and 98.9%(RSD=0.6%),respectively. The limit of detection was 0.3 ng. The related substances gained a completely chromatography separation with the principal peak. The present method is accurate, sensitive and simple, which provides a new reliable analytical method for the quality control of clodronate disodium and its preparations.
