HPLC法测定鼻炎康片中马来酸氯苯那敏的含量.doc

HPLC法测定鼻炎康片中马来酸氯苯那敏的含量
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【摘要】[目的]建立HPLC法测定鼻炎康片中马来酸氯苯那敏的含量。[方法]采用Phenomenex C18 Gemini(250×,5u)色谱柱,柱温为室温,以甲醇庚烷磺酸钠冰醋酸混合溶液(60∶40);·min-1;检测波长:224nm。[结果] ~(r=),%,RSD=%(n=5)。[结论]方法简便,结果准确,可作为本品质量控制的有效方法。
【关键词】 HPLC; 鼻炎康片; 马来酸氯苯那敏
Abstract: [Objective] To establish an HPLC method for the quantitative determination of Chlorphenamine Maleate in Biyankang Tablets.[Methods]The determination was performed on Phenomenex C18 column with the mobile phase consisted of methanol mixed solution of sodium heptane sulfonate and glacial acetic acid(60∶40,adjuseted to with triethylaminum) at ambient flow
rate was ·min- detection wavelength was set at 224nm.[Results]The method showed a good linear relationship within the range of Chlorphenamine Maleate ~ (r=,n=5).The average recovery was % with RSD=% (n =5).[Conclusion]The method is simple and accurate and could be used for quality control of Biyankang Tablets.
Key words:HPLC; Biyankang Tablets; Chlorphenamine Maleate
鼻炎康片为临床上治疗急慢性鼻炎的常用中成药,由广藿香、苍耳子、鹅不食草、当归、黄芩、马来酸氯苯那敏等多味药组成。目前为止没有报道成品中马来酸氯苯那敏的含量测定方法,为了更有效的控制产品质量,笔者现参照马来酸氯苯那敏含量测定的相关文献资料[12],建立用高效液相色谱法测定鼻炎康片中马来酸氯苯那敏含量的方法,方法简便,重现性好。
1 仪器与试药
Waters2695型液相色谱仪,Waters2996二极管阵列检测器,Empower色谱工作站;色谱柱: