中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2014年
2期
94-98
,共5页
普卢利沙星片%有关物质%含量测定%高效液相色谱法
普盧利沙星片%有關物質%含量測定%高效液相色譜法
보로리사성편%유관물질%함량측정%고효액상색보법
prulifloxacin tablets%related substances%determination%HPLC
目的：完善普卢利沙星片含量及有关物质的检测方法。方法：采用C18色谱柱，以0.1％磷酸溶液（三乙胺调节pH值至4.0）为流动相A，乙腈为流动相B，含量测定采用等度洗脱流动相A-流动相B（55∶45），有关物质采用梯度洗脱，检测波长为278nm。结果：主峰和杂质峰能得到良好的分离，普卢利沙星在12.9～413.8μg·mL-1浓度范围内，杂质NM394在1.23～39.36μg·mL-1浓度范围内呈良好线性关系；含量测定平均回收率为101.3％，RSD为1.46％（n＝9）。结论：该法专属性强，灵敏、准确，可作为普卢利沙星片的质量控制方法。
目的：完善普盧利沙星片含量及有關物質的檢測方法。方法：採用C18色譜柱，以0.1％燐痠溶液（三乙胺調節pH值至4.0）為流動相A，乙腈為流動相B，含量測定採用等度洗脫流動相A-流動相B（55∶45），有關物質採用梯度洗脫，檢測波長為278nm。結果：主峰和雜質峰能得到良好的分離，普盧利沙星在12.9～413.8μg·mL-1濃度範圍內，雜質NM394在1.23～39.36μg·mL-1濃度範圍內呈良好線性關繫；含量測定平均迴收率為101.3％，RSD為1.46％（n＝9）。結論：該法專屬性彊，靈敏、準確，可作為普盧利沙星片的質量控製方法。
목적：완선보로리사성편함량급유관물질적검측방법。방법：채용C18색보주，이0.1％린산용액（삼을알조절pH치지4.0）위류동상A，을정위류동상B，함량측정채용등도세탈류동상A-류동상B（55∶45），유관물질채용제도세탈，검측파장위278nm。결과：주봉화잡질봉능득도량호적분리，보로리사성재12.9～413.8μg·mL-1농도범위내，잡질NM394재1.23～39.36μg·mL-1농도범위내정량호선성관계；함량측정평균회수솔위101.3％，RSD위1.46％（n＝9）。결론：해법전속성강，령민、준학，가작위보로리사성편적질량공제방법。
Objective:To perfect the HPLC method for determination and related substances of prulifloxacin tablets.Methods: The separation was performed on a C18 column with a mixture of 0.1%phosphoric acid solution ( three triethylamine adjusted to pH4) as mobile phase A, acetonitrile as mobile phase B, isocratic elution A:B (55∶45) for determination and gradient elution for related sub-stances.The UV detection wavelength was 278 nm.Results:Prulifloxacin was well separated from other impurities.The calibration curve of prulifloxacin was linear in the range of 12.9-413.8 μg· mL-1.The calibration curve of impurity NM 394 was linear in the range of 1.23-39.36 μg · mL-1.The average recoveries ( n=9 ) was 101.3% ( RSD =1.46%).Conclusion: The method is proved to be specific , sensitive and accurate and could be used to control the quality of prulifloxacin tablets .
