HPLC Analysis of Azithromycin and all kinds of injection in the content of related substances.docVIP

 PAGE \* MERGEFORMAT 16 HPLC Analysis of Azithromycin and all kinds of injection in the content of related substances Author: Wang Mingjuan Wang Lixin Wang Ming-Je Shiu HU Chang-Qin * [Abstract] Objective To establish a raw material can be used to azithromycin and preparations relating to the material-controlled HPLC method. Methods XBridge Shield RP18 column (250mm * 4.6mm, 5μ m), column temperature 30 ℃ , mobile phase of acetonitrile: pH8.2 phosphate buffer (0.05mol / L dipotassium hydrogen phosphate solution, with 20% phosphoric acid to adjust pH 8.2) (55:45), flow rate 1.0ml/min; detection wavelength 210nm; sample solution into the sample volume of 200μ g. The results of azithromycin and its impurities (aza-erythromycin A, erythromycin A oxime, N  norepinephrine Jia Qi, Azithromycin Azithromycin Germany glucosamine and N  oxide) to achieve baseline separation; hydrochloric acid, sulfuric acid, lactose acid, citric acid , maleic acid, etc. Azithromycin Injection Azithromycin commonly used in acid radical right had no effect on the determination of related substances; method of linearity, accuracy, sensitivity, and extensive nature are able to meet the requirements. Conclusion This method can built to reflect a variety of domestic raw materials and preparation of azithromycin in the material conditions for the domestic market azithromycin injection of different evaluation of azithromycin and its oral preparation quality control provides a better analytical tools. [Keywords:] azithromycin; the material; raw materials; preparation ABSTRACT Objective To develop an HPLC method for determination the related substances of azithromycin in parenteral products. Method The separation was performed on a column of XBridge Shield RP18 (250mm * 4.6mm, 5μ m), with acetonitrile: pH8.2 phosphate buffer (0.05mol / L K2HPO4 solution, adjust pH to 8.2 with 20% phosphate acid) (55:45) as the mobile phase at flow rate of 1.0ml/min. The detection wavelength was 210 nm. The