中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2015年
4期
254-257
,共4页
盐酸羟苄唑滴眼液%高效液相色谱法%有关物质
鹽痠羥芐唑滴眼液%高效液相色譜法%有關物質
염산간변서적안액%고효액상색보법%유관물질
Hydrobenzole Hydrochloride Eye Drops%HPLC%related substance
目的：：采用紫外-二极管阵列-高效液相色谱法对盐酸羟苄唑滴眼液中的有关物质进行分析。方法：以十八烷基硅烷键合硅胶为填充剂,流动相为甲醇-水-醋酸-三乙胺(20∶80∶3∶0．3),流量为1．0 mL·min-1,检测波长为277 nm。结果：在选定的色谱条件下,羟苄唑与各杂质峰均能良好地分离,方法学考察符合分析检测要求。结论：本方法灵敏度高,重现性好,专属性强,可用于盐酸羟苄唑滴眼液中有关物质的检测。
目的：：採用紫外-二極管陣列-高效液相色譜法對鹽痠羥芐唑滴眼液中的有關物質進行分析。方法：以十八烷基硅烷鍵閤硅膠為填充劑,流動相為甲醇-水-醋痠-三乙胺(20∶80∶3∶0．3),流量為1．0 mL·min-1,檢測波長為277 nm。結果：在選定的色譜條件下,羥芐唑與各雜質峰均能良好地分離,方法學攷察符閤分析檢測要求。結論：本方法靈敏度高,重現性好,專屬性彊,可用于鹽痠羥芐唑滴眼液中有關物質的檢測。
목적：：채용자외-이겁관진렬-고효액상색보법대염산간변서적안액중적유관물질진행분석。방법：이십팔완기규완건합규효위전충제,류동상위갑순-수-작산-삼을알(20∶80∶3∶0．3),류량위1．0 mL·min-1,검측파장위277 nm。결과：재선정적색보조건하,간변서여각잡질봉균능량호지분리,방법학고찰부합분석검측요구。결론：본방법령민도고,중현성호,전속성강,가용우염산간변서적안액중유관물질적검측。
Objective:To establish an UV-DAD-HPLC method to analyse the related substances of Hydrobenzole Hydrochloride Eye Drops. Method:A C18 column (4. 6 mm × 150 mm,5 μm) was adopted with the mobile phase of methanol-water-acetic acid-triethyl-amine (20∶80∶3∶0. 3), the flow rate was 1. 0 mL·min-1 and the detection wavelength was 277 nm. Result:Hydrobenzole and impu-rity peaks could be well separated under the selected HPLC conditions, the methodological studies conformed to the requirements for a-nalysis. Conclusion:The method is sensitive, reproducible and specific, which could be used to analyse the related substances of Hydrobenzole Hydrochloride Eye Drops.
