摘要
目的建立测定滴眼用利福平片中特殊杂质醌式利福平、N-氧化利福平、3-甲酰利福霉素SV及其余有关物质含量的HPLC法。方法采用Luna C8色谱柱,甲醇∶乙腈∶0.075mol/L磷酸二氢钾溶液∶1.0mol/L枸橼酸溶液(29∶32∶34∶4)为流动相;检测波长为254nm。醌式利福平、N-氧化利福平、3-甲酰利福霉素SV均采用加校正因子的主成分自身对照法计算。结果醌式利福平、N-氧化利福平和3-甲酰利福霉素SV的校正因子分别为1.4、1.67和1.08,3批样品中醌式利福平、N-氧化利福平、3-甲酰利福霉素SV及其余有关物质含量分别为1.1%～1.3%、0.050%～0.053%、0.025%～0.031%及0.79%～0.86%。结论该法准确、简便、快速,适用于滴眼用利福平片的质量控制。
Objective To establish an RP-HPLC method for content determination of rifampicin quinone,rifampicin N-oxid and 3-formylrifamycin SV in rifampicin tablets for eyedrops. Methods HPLC method was performed with Luna C8 column（150mm × 4.6mm, 5μm）, 254nm detection wavelength, and the mobile phase consisting of methanol： acetonitrile： 0. 075mol/L potassium dihydrogen phosphate： 1.0mol/L citric acid （29： 32： 34： 4）. The flow rate was 1.0ml/min. The contents of rifampicin quinone rifampicin N-oxid and 3-formylrifamycin SV in the sample of rifampicin tablets for eyedrops taken was caculated by self control with reponse factor impurity relative to that of sample. Results The reponse factor of rifampicin quinone, rifampicin N-oxid, 3-formylrifamycin SV relative to that of rifampicin was 1.0, 1.4, 1.67 and 1.08, respectively. The contents of rifampicin quinone, rifampicin N-oxid, 3-formylrifamycin SV and related impurities was 1.1% - 1.3%, 0.050% - 0. 053%, 0. 025% - 0.031% and 0.79%-0. 86%, respectively in three latches of samples. Conclusion The HPLC method is accurate, simple and rapid for the content determination of rifampicm tablets for eyedrops and could be used for its quality control.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2008年第4期214-216,227,共4页
Chinese Journal of Antibiotics
