中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2014年
2期
115-117
,共3页
氯霉素滴眼液%苯扎溴铵%高效液相色谱法
氯黴素滴眼液%苯扎溴銨%高效液相色譜法
록매소적안액%분찰추안%고효액상색보법
chloramphenicol eye drops%benzalkonium bromide%HPLC
目的：建立HPLC测定氯霉素滴眼液中苯扎溴铵含量的方法。方法：采用苯基硅烷键合硅胶为固定相；流动相为0.05 moL· L-1磷酸二氢钾溶液（用三乙胺调节pH值至5.5）-乙腈（40∶60）；检测波长220 nm；流量1.2 mL· min-1；柱温40℃；进样量20μL。结果：苯扎溴铵在0.0304～1.218μg范围内呈良好的线性关系（r＝0.9998）；检测限为3.45 ng，定量限为6.9 ng；平均回收率为99.8％（n＝9），RSD＝1.5％。结论：该方法准确、可靠，可有效控制氯霉素滴眼液中苯扎溴铵的含量。
目的：建立HPLC測定氯黴素滴眼液中苯扎溴銨含量的方法。方法：採用苯基硅烷鍵閤硅膠為固定相；流動相為0.05 moL· L-1燐痠二氫鉀溶液（用三乙胺調節pH值至5.5）-乙腈（40∶60）；檢測波長220 nm；流量1.2 mL· min-1；柱溫40℃；進樣量20μL。結果：苯扎溴銨在0.0304～1.218μg範圍內呈良好的線性關繫（r＝0.9998）；檢測限為3.45 ng，定量限為6.9 ng；平均迴收率為99.8％（n＝9），RSD＝1.5％。結論：該方法準確、可靠，可有效控製氯黴素滴眼液中苯扎溴銨的含量。
목적：건립HPLC측정록매소적안액중분찰추안함량적방법。방법：채용분기규완건합규효위고정상；류동상위0.05 moL· L-1린산이경갑용액（용삼을알조절pH치지5.5）-을정（40∶60）；검측파장220 nm；류량1.2 mL· min-1；주온40℃；진양량20μL。결과：분찰추안재0.0304～1.218μg범위내정량호적선성관계（r＝0.9998）；검측한위3.45 ng，정량한위6.9 ng；평균회수솔위99.8％（n＝9），RSD＝1.5％。결론：해방법준학、가고，가유효공제록매소적안액중분찰추안적함량。
Objective:To establish an HPLC method for the determination of benzalkonium bromide in chloramphenicol eye drops .Methods:Phenyl silane bonded silica gel was adopted as stationary phase with a mixture of 0.05 moL· L-1 potassium dihydrogenphos-phate solution (triethylamine adjusted pH to 5.5 ) and acetonitrile (40∶60) as mobile phase at the flow rate 1.2 mL· min-1.The de-tecting wavelength was set at 220 nm, the column temperature was 40 ℃and the injection volume was 20 μL.Results:A good linear relationship of benzalkonium bromide was achieved in the range of 0.0304-1.218 μg( r=0.9998 ) ,limit of detection was 3.45 ng and limit of quantitation was 6.9 ng.The average recovery was 99.8%(n=9),RSD=1.5%.Conciusion:The method is accurate, relia-ble and could be used to control the quality of benzalkonium bromide in chloramphenicol eye drops effectively .
