Zhou Xin
2005
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Journal
Chinese Journal of Pharmaceutical Analysis
Abstract
To establish an analytical method of high performance capillary electrophoresis (HPCE) to determine the content of rufloxacin hydrochloride preparations and compare HPCE method with the method of high performance liquid chromatography (HPLC).Methods:The determination was performed on a fused silica capillary (75μm×365μm,62 cm in total length and 53.5 cm to the detector).Optimized analytical conditions are as fol- lows:running buffer system of 20 mmol·L~(-1) borate-25 mmol·L~(-1) phosphate buffer with pH 8.7,18 kV applied voltage,temperature 28℃ and UV detection at 295 nm.The external standard method (ESM) and the internal standard method (ISM) were used as the quantitative methods of HPCE.ESM was used as the quantitative method of HPLC.Results:The linearity range is 1.4×10~(-6) -5.7×10~(-5)mol·L~(-1) (r=0.9997) for ESM and 1.6×10~(-6)- 1×10~(-4) mol·L~(-1) (r=0.9997) for ISM.The detection limit and the quantification limit of rufloxacin hydrochloride is 5×10~(-7)mol·L~(-1) and 1.4×10~(-6)mol·L~(-1) respectively for ESM,and 5.1×10~(-7)mol·L~(-1) and I.6×10~(-6)mol ·L~(-1) respectively for ISM.The quantitative precision of ESM is 1.02%-1.73% for intra-day and 1.90%- 3.84% for inter-day,and that of ISM 0.84%-1.33% for intra-day and 1.83%-2.40% for inter-day.The recovery of ESM is 99.6% (98.5%-100.5%) for capsules and 99.4% (98.6%-100.1% ) for tablets.The re- covery of ISM is 100.3% (99.2%-102.0%) for capsules and 99.5% (99.4%-99.6% ) for tablets..Conclu- sions:HPCE method is much more simple,rapid and economic than HPLC method.Moreover,the results determined by HPCE method (ESM and ISM) are exact,reproducible and consistent with that determined by HPLC method.So HPCE method can be used to control the quality of rufloxacin hydrochloride capsules and tablets.