北方药学
北方藥學
북방약학
JOURNAL OF NORTH PHARMACY
2014年
11期
10-11,12
,共3页
刘利%周凡%胡志林
劉利%週凡%鬍誌林
류리%주범%호지림
高效液相色谱法%板蓝根颗粒%清洁验证%R,S-表告依春
高效液相色譜法%闆藍根顆粒%清潔驗證%R,S-錶告依春
고효액상색보법%판람근과립%청길험증%R,S-표고의춘
HPLC%BanLangen GranuLes%ResiduaL vaLue cLeaning vaLidation%R,S-epigoitrin
目的:建立板蓝根颗粒清洁验证的HPLC法。方法:色谱柱为C18柱;流动相为甲醇:0.02%磷酸水溶液(7∶93);检测波长245nm;流速0.8ml/min;柱温30℃;进样量10μL。理论板数按R,S-表告依春峰计应不得低于5000。结果:板蓝根颗粒中表告依春的含量在3.9~95μg/ml (A=85322C-72006,r=0.9995)内呈良好线性关系,平均回收率102.80%,RSD 1.22%;表告依春的残留量在0.04~1.0μg/ml(A=90115C-13204,r=0.9997)内呈良好线性关系。结论:方法简便,稳定可靠,可以用于板蓝根颗粒中表告依春的质量控制;清洁后水样中表告依春的残留量低于限度。
目的:建立闆藍根顆粒清潔驗證的HPLC法。方法:色譜柱為C18柱;流動相為甲醇:0.02%燐痠水溶液(7∶93);檢測波長245nm;流速0.8ml/min;柱溫30℃;進樣量10μL。理論闆數按R,S-錶告依春峰計應不得低于5000。結果:闆藍根顆粒中錶告依春的含量在3.9~95μg/ml (A=85322C-72006,r=0.9995)內呈良好線性關繫,平均迴收率102.80%,RSD 1.22%;錶告依春的殘留量在0.04~1.0μg/ml(A=90115C-13204,r=0.9997)內呈良好線性關繫。結論:方法簡便,穩定可靠,可以用于闆藍根顆粒中錶告依春的質量控製;清潔後水樣中錶告依春的殘留量低于限度。
목적:건립판람근과립청길험증적HPLC법。방법:색보주위C18주;류동상위갑순:0.02%린산수용액(7∶93);검측파장245nm;류속0.8ml/min;주온30℃;진양량10μL。이론판수안R,S-표고의춘봉계응불득저우5000。결과:판람근과립중표고의춘적함량재3.9~95μg/ml (A=85322C-72006,r=0.9995)내정량호선성관계,평균회수솔102.80%,RSD 1.22%;표고의춘적잔류량재0.04~1.0μg/ml(A=90115C-13204,r=0.9997)내정량호선성관계。결론:방법간편,은정가고,가이용우판람근과립중표고의춘적질량공제;청길후수양중표고의춘적잔류량저우한도。
Objective:To estabLish an HPLC method of BanLangen GranuLes’ cLeaning vaLidation.Method:The sampLes were used with C18 and the mobiLe phase of methanoL-0.02% phosphate (7∶93).The fLow rate was set at 0.8ml/min and the detection waveLength was set at 245nm.CoLumn temperature was 30℃ and sampLe voLume was 10uL.TheoreticaL pate number shaLL not be than 5000.ResuLts:The Linear range was3.9~95μg/ml (A=85322C-72006 r=0.9995),and the average recovery was 102.8% with the RSD was 1.22%.The residuaL of epigoitrin from 0.04 to 1.0μg/ml (A=90115C-1320.4 r=0.9997) in Linear.ConcLusion :This method is convenient, repeatabLe and reLiabLe, and couLd be used for the quantitative controL of BanLangen granuLes; After cLeaning the residues in the water was Lesser than epigotrin by Limit residues.