title: Development of a sensitive and rapid method for rifampicin impurity analysis using supercritical fluid chromatography.
abstract: A novel simple, fast and efficient supercritical fluid chromatography (SFC) method was developed and compared with RPLC method for the separation and determination of impurities in rifampicin. The separation was performed using a packed diol column and a mobile phase B (modifier) consisting of methanol with 0.1% ammonium formate (w/v) and 2% water (v/v). Overall satisfactory resolutions and peak shapes for rifampicin quinone (RQ), rifampicin (RF), rifamycin SV (RSV), rifampicin N-oxide (RNO) and 3-formylrifamycinSV (3-FR) were obtained by optimization of the chromatography system. With gradient elution of mobile phase, all of the impurities and the active were separated within 4 min. Taking full advantage of features of SFC (such as particular selectivity, non-sloping baseline in gradient elution, and without injection solvent effects), the method was successfully used for determination of impurities in rifampicin, with more impurity peaks detected, better resolution achieved and much less analysis time needed compared with conventional reversed-phase liquid chromatography (RPLC) methods.
authors.affiliation: Department of Analytical Chemistry, China Pharmaceutical University, 24 Tongjia Lane, Nanjing 210009, China; Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, 4 Tongjia Lane, Nanjing 210009, China; Department of Antibiotics, Anhui Institute for Food and Drug Control, Hefei 230051, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.affiliation: School of Medical Engineering, Hefei University of Technology, Hefei 230009, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Analytical Chemistry, China Pharmaceutical University, 24 Tongjia Lane, Nanjing 210009, China; Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, 4 Tongjia Lane, Nanjing 210009, China. Electronic address: yanzhengyujiang@163.com.
authors.forename: Zheng-Yu
authors.initials: ZY
authors.lastname: Yan
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D025924:Chromatography, Supercritical Fluid / Q000379:methods*; D004340:Drug Contamination; D015203:Reproducibility of Results; D012293:Rifampin / Q000031:analogs & derivatives / Q000032:analysis*; D012294:Rifamycins / Q000032:analysis; D012997:Solvents; D013696:Temperature
chemical_list: D012294:Rifamycins; D012997:Solvents; C038966:3-formylrifamycin SV; C027468:dehydrorifampicin; C043640:rifampicin N-oxide; C023808:rifamycin SV; D012293:Rifampin
keywords: Impurity analysis; Rifampicin; Supercritical fluid chromatography