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中文摘要：
目的：优化高效液相色谱法检测罗红霉素含量的最佳流动相条件，改善现行方法中主峰拖尾现象。方法：选取流动相中缓冲液浓度、pH值、三乙胺含量、乙腈用量为影响因素，以罗红霉素色谱峰拖尾因子（T1）、保留时间（tn）、半峰宽（W1/2）及理论板数（N）为考察指标，设计正交试验优化含量测定方法并与2010年版《中国药典》含量测定方法比较。结果：优化后含量测定方法：用十八烷基硅烷键合硅胶为填充剂，流动相：O．067mol·L^-1磷酸二氢铵溶液（三乙胺含量O．3％，调pH值至7．5）．乙腈（60：40），检测波长：205nm，柱温：30℃，流速：1．0mL·min^-1，进样量：20μL。优化后方法与药典方法的比较结果：L为1．2、1．9；tR为14．133、12．383min；W1/2为0．400、0．533；N为6916、2987。结论：优化后方法较2010年版《中国药典》方法提高了柱效，延长了保留时间，较好地改善了色谱峰拖尾严重的状况。
英文摘要：
OBJECTIVE： To optimize mobile phase condition of content determination of roxithromycin by HPLC, and to improve peak tailing. METHODS： Using buffer concentration, pH value of mobile phase, amount of triethylamine and acetonitrile as factors and with tailing factor （T1）, retention time （tR）, half-peak width （W1/2） and theoretical plate number （N） as index, the determination method was optimized by orthogonal and compared with content determination method stated in Chinese Pharmacopeia （2010 edition）. RESULTS： Optimal condition was as follows： Ct8 column was used, mobile phases consisted of 0.067 mol.L^-1 ammonium dihydrogen phosphate （0.3%TEA, pH=7.5）-acetonitrile （60：40） at flow rate of 1.0 mL.min^-1 and the detection wavelength was set at 205 mn. The injection volume was 20 μL and the column temperature was 30 ℃. Optimized method was com- pared with that stated in Chinese Pharmacopoeia. T1 were 1.2 and 1.9; tR were 14.133 min and 12.383 min; W1/2 were 0.400 and 0.533; N were 6 916 and 2 987. CONCLUSION： Compared with the current method in Chinese Pharmacopoeia （2010 edition）, the optimal method is better in term of column efficiency, prolonging retention time and improving peak tailing.
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