HPLC法测定注射用乳糖酸阿奇霉素中的有关物质.docVIP

HPLC法测定注射用乳糖酸阿奇霉素中的有关物质 　　[摘要] 目的 建立高效液相色谱法测定注射用乳糖酸阿奇霉素的有关物质。 方法 采用高效液相色谱法测定已知杂质以及未知单杂。使用BDS HYPERSIL C18色谱柱（250mm×4.6mm，5μm），以乙腈∶pH8.2磷酸盐缓冲液（0.05mol/L磷酸氢二钾溶液， 用20%磷酸调节pH至8.2）（55∶45）为流动相。样品溶液的进样量为200μg，流速：1.5mL/min，检测波长：293nm。 结果 乳糖酸阿奇霉素与其杂质能达到基线分离，且阿奇霉素注射剂中的酸根对阿奇霉素的有关物质测定无影响，供试品溶液的浓度与峰面积线性良好，方法的准确性以及灵敏度均可满足要求。 结论 该方法简便、专属性好、灵敏度高，能较好反映各种乳糖酸阿奇霉素制剂中的有关物质的情况。 　　[关键词] 高效液相色谱法；乳糖酸阿奇霉素；有关物质；制剂 　　[中图分类号] R927 [文献标识码] B [文章编号] 2095-0616（2014）13-97-03 　　[Abstract] Objective To establish the determination method of the related substances in azithromycin lactobionate and its injection. Methods High performance liquid chromatography（HPLC）was used for the determination of the known impurity and the unknown impurities. The analysis was performed on a BDS HYPERSIL C18 column （250mm×4.6mm， 5μm）. The mobile phase was composed of acetonitrile∶pH8. 2 phosphate buffer （0.05mol/L K2HPO4 solution， adjust pH to 8.2 with 20% phosphate acid） （ 55∶45） ，the injection amounts of sample solutions were 200μg，with the flow of 1.5mL/min.The detection wavelength was 293nm. Results Azithromycin lactobionate and its related substances can be well separated from each other on the developed system. The co-existence acids in azithromycin for injection did not interfere with the determination of the related substances. The chromatographic peak area and concentration of moxacin hydrochloride showed a good linear relationship。Accuracy and sensitivity of the method could meet the specific analytical requirements. Conclusion The developed method is convenient， a good specificity， high sensitivity. It can be used to determine the related substances in azithromycin lactobionate and its injection. 　　[Key words] HPLC； Azithromycin lactobionate； Related substances； Drug products 　　阿奇霉素在水中几乎不溶解，但在稀酸溶液中易溶，且其对酸较敏感，在酸溶液中可使其完全降解[1-2]。中国药典2005年版中收载有阿奇霉素，目前常用盐酸、硫酸、乳糖酸、马来酸、门冬氨酸阿奇霉素以及阿奇霉素磷酸二氢钠、阿奇霉素柠檬酸二氢钠及相应的注射剂（粉针，小针剂及大输液）[3]。有关物质检查是目前药品安全性评价的一个重要指标。HPLC法是最常用的有关物质检查方法之一[4]。近年，我国呼吸系统感染发病率直线上升，本品需求量稳步攀升，已逐渐成为治疗呼吸道