中国药物应用与监测
中國藥物應用與鑑測
중국약물응용여감측
CHINESE JOURNAL OF DRUG APPLICATION AND MONITORING
2014年
6期
348-350
,共3页
白林%范金钊%蔡乐%徐风华
白林%範金釗%蔡樂%徐風華
백림%범금쇠%채악%서풍화
高效液相色谱法%盐酸苯海拉明乳膏%含量测定
高效液相色譜法%鹽痠苯海拉明乳膏%含量測定
고효액상색보법%염산분해랍명유고%함량측정
HPLC%Diphenhydramine hydrochloride cream%Content determination
目的：建立测定盐酸苯海拉明乳膏含量的方法。方法：采用HPLC法，色谱柱：Platisil C18柱（250 mm×4.6 mm，5μm）；流动相：乙腈-水-三乙胺（50∶50∶0.5）；检测波长：258 nm；流速：0.8 mL·min-1；柱温：40℃。结果：盐酸苯海拉明与其它杂质峰分离良好。盐酸苯海拉明在125.0~1000.0μg·mL-1范围内与峰面积呈良好的线性关系（r =1.0000）；盐酸苯海拉明的平均回收率为98.18%，RSD =0.40%（n =9）。结论：本方法简便、准确、重复性好，可用于盐酸苯海拉明乳膏的含量测定。
目的：建立測定鹽痠苯海拉明乳膏含量的方法。方法：採用HPLC法，色譜柱：Platisil C18柱（250 mm×4.6 mm，5μm）；流動相：乙腈-水-三乙胺（50∶50∶0.5）；檢測波長：258 nm；流速：0.8 mL·min-1；柱溫：40℃。結果：鹽痠苯海拉明與其它雜質峰分離良好。鹽痠苯海拉明在125.0~1000.0μg·mL-1範圍內與峰麵積呈良好的線性關繫（r =1.0000）；鹽痠苯海拉明的平均迴收率為98.18%，RSD =0.40%（n =9）。結論：本方法簡便、準確、重複性好，可用于鹽痠苯海拉明乳膏的含量測定。
목적：건립측정염산분해랍명유고함량적방법。방법：채용HPLC법，색보주：Platisil C18주（250 mm×4.6 mm，5μm）；류동상：을정-수-삼을알（50∶50∶0.5）；검측파장：258 nm；류속：0.8 mL·min-1；주온：40℃。결과：염산분해랍명여기타잡질봉분리량호。염산분해랍명재125.0~1000.0μg·mL-1범위내여봉면적정량호적선성관계（r =1.0000）；염산분해랍명적평균회수솔위98.18%，RSD =0.40%（n =9）。결론：본방법간편、준학、중복성호，가용우염산분해랍명유고적함량측정。
[ABSTRACT]Objective: To establish the HPLC method for determining the content of diphenhydramine hydrochloride cream.Methods:HPLC analysis was carried out with Platisil C18column (250 mm×4.6 mm, 5μm), the mobile phase consisted of acetonitrile-water-triethylamine (50 : 50 : 0.5), the detection wavelength was 258 nm, the flow rate was 0.8 mL·min-1 and the column temperature was 40℃.Results:The samples were separated well from impurities by this HPLC method. The calibration curve of diphenhydramine hydrochloride was linear in the range of 125.0 – 1 000.0μg·mL-1 (r = 1.000 0). The average recovery and the RSD of diphenhydramine hydrochloride were 98.18%, 0.40% (n = 9), respectively.Conclusion:This method is accurate and feasible, which can be applied as the quantitative method for the determination of diphenhydramine hydrochloride cream.
