Chloride ion chromatography and its preparations phosphonic acid disodium content and related substances.docVIP

 PAGE \* MERGEFORMAT 13 Chloride ion chromatography and its preparations phosphonic acid disodium content and related substances [Abstract] suppressed conductivity detection of chloride ion chromatography and its preparations disodium phosphate content and related substances. Chromatographic conditions for the anion exchange column (IonPac AS11 HC), suppressed conductivity detection method for the detection, column temperature 30 ℃, the flow rate 1.2 mL / min, with KOH solution as the eluent concentration was determined by isocratic elution, gradient elution related substances. chloro acid disodium in 0.0568 ~ 0.1895 g / L a good linear relationship ( r = 0.9999), injection and capsules, the average recovery was 100.1% (RSD = 0.7%) and 98.9% (RSD = 0  6%), the detection limit was 0.3 ng. The peaks of impurities and main components can completely separated. [Keywords:]-ion chromatography, chloride acid disodium 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 preparation