药学研究
藥學研究
약학연구
JOURNAL OF PHARMACEUTICAL RESEARCH
2015年
5期
280-281
,共2页
克霉唑阴道片%高效液相色谱法%含量
剋黴唑陰道片%高效液相色譜法%含量
극매서음도편%고효액상색보법%함량
Clotrimazole Vaginal Tablets%HPLC method%Content
目的：建立克霉唑阴道片含量的高效液相色谱测定方法。方法采用大连依利C18色谱柱，流动相为甲醇-磷酸缓冲液（取磷酸5 mL，加50%甲醇溶液稀释至1000 mL，用三乙胺调节pH值至3.8）（40：60），流速：1.0 mL·min-1，检测波长230 nm，进样量为10μL。结果在该色谱条件下，克霉唑在浓度为0.025~0.2 mg·mL-1范围内线性关系良好，回归方程为：A=30397C-3.35383，r=0.9999，重复性试验RSD为1.35%，平均回收率为96.67%（RSD=1.33%）。结论本法灵敏、简便、准确、重复性好，能有效控制克霉唑阴道片的含量。
目的：建立剋黴唑陰道片含量的高效液相色譜測定方法。方法採用大連依利C18色譜柱，流動相為甲醇-燐痠緩遲液（取燐痠5 mL，加50%甲醇溶液稀釋至1000 mL，用三乙胺調節pH值至3.8）（40：60），流速：1.0 mL·min-1，檢測波長230 nm，進樣量為10μL。結果在該色譜條件下，剋黴唑在濃度為0.025~0.2 mg·mL-1範圍內線性關繫良好，迴歸方程為：A=30397C-3.35383，r=0.9999，重複性試驗RSD為1.35%，平均迴收率為96.67%（RSD=1.33%）。結論本法靈敏、簡便、準確、重複性好，能有效控製剋黴唑陰道片的含量。
목적：건립극매서음도편함량적고효액상색보측정방법。방법채용대련의리C18색보주，류동상위갑순-린산완충액（취린산5 mL，가50%갑순용액희석지1000 mL，용삼을알조절pH치지3.8）（40：60），류속：1.0 mL·min-1，검측파장230 nm，진양량위10μL。결과재해색보조건하，극매서재농도위0.025~0.2 mg·mL-1범위내선성관계량호，회귀방정위：A=30397C-3.35383，r=0.9999，중복성시험RSD위1.35%，평균회수솔위96.67%（RSD=1.33%）。결론본법령민、간편、준학、중복성호，능유효공제극매서음도편적함량。
Objective To establish an HPLC method for the determination of Clotrimazole Vaginal Tablets. Methods Dalian C18 chromatographic column was adopted with methanol-phosphate buffer( phosphate from 5 mL and 50% methanol solution was diluted to 1 000 mL,with three procedures for adjusting the pH value to 3. 8)(40:60)as mobile phase,and the flow rate was 1. 0 mL·min-1 ,the detection wavelength was 230 nm,the injection volume was 10 μL. Results Under the chromatographic conditions,the linear range of clotrimazole was 0. 025~ 0. 2 mg·mL-1 ,the regression equation was A=30 397C-3. 353 83,r=0. 999 9. The RSD of repeatability test was 1. 35%,the average recovery rate was 96. 67%(RSD=1. 33%). Conclusion This method was sensitive,simple,accurate,reproducible,and can effectively control the content of Clotrimazole Vaginal Tablets.
