Nirogi Ramakrishna, Kota Srinivasulu, Vennila Saritha, Lingavarapu Bujjibabu, Kandikere Vishwottam, Mudigonda Koteshwara, Vurimindi Hima Bindu
Suven Life Sciences Limited, Serene Chambers, Road 5, Avenue 7, Banjara Hills, Hyderabad - 500034, India.
J Chromatogr Sci. 2010 Feb;48(2):100-3. doi: 10.1093/chromsci/48.2.100.
A high-performance liquid chromatographic method has been developed in normal-phase conditions for the separation of enantiomeric gatifloxacin, (+/-) 1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxo-quinoline-3-carboxylic acid, an antibiotic in bulk drug. The method involved the use of an amylose-based Chiralpak AD-H (150 mm x 4.6 mm, 5 microm) column using a mobile phase system containing n-hexane-ethanol-diethylamine (85:15:0.1% v/v). The conditions affording the best resolution were found by selection and variation of the mobile-phase compositions and the differences in separation capability of the method is noted. Relative standard deviation of retention times and peak areas were better than 0.2% and 0.4%, respectively, for precision. Gatifloxacin sample solution and mobile phase are found to be stable for at least 48 h.
已开发出一种在正相条件下分离对映体加替沙星（±）1-环丙基-6-氟-8-甲氧基-7-（3-甲基哌嗪-1-基）-4-氧代喹啉-3-羧酸（一种原料药抗生素）的高效液相色谱方法。该方法使用基于直链淀粉的Chiralpak AD-H（150 mm×4.6 mm，5μm）柱，流动相体系为正己烷-乙醇-二乙胺（85:15:0.1% v/v）。通过选择和改变流动相组成找到了提供最佳分离度的条件，并记录了该方法分离能力的差异。保留时间和峰面积的相对标准偏差分别优于0.2%和0.4%，精密度良好。加替沙星样品溶液和流动相至少在48小时内稳定。
