非水电位滴定法测定盐酸非索非那定原料药含量方法的改进
|
摘要
目的:改进非水电位滴定法测定盐酸非索非那定原料药含量的方法。方法:采用电位滴定法,以冰醋酸-醋酐(1∶3)为溶剂,革除现行标准中醋酸汞的使用,建立了测定盐酸非索非那定原料药含量的方法。结果:改进后的方法突跃明显增大,测定结果与高效液相色谱法测定结果无显著差异。结论:改进后的方法不但革除了醋酸汞的使用,且操作简便、快速、重复性好,可用于盐酸非索非那定原料药的含量测定。
Objective: To optimize the determination method of fexofenadine hydrochloride by non-aqueous potentiometric titration. Methods: The new determination method of fexofenadine hydrochloride was established with nonaqueous potentiometric titration. Glacial acetic acid-acetic anhydride( 1 ∶ 3) was used as the solvent to avoid the use of mercuric acetate. Results: The optimized method had the sharpness titration jump. There was no significant difference between the results obtained by the improved method and HPLC method. Conclusion: The optimized method avoids the use of mercuric acetate. It is simple and rapid,and has the good repeatability. It can be used for the determination of fexofenadine hydrochloride.
Objective: To optimize the determination method of fexofenadine hydrochloride by non-aqueous potentiometric titration. Methods: The new determination method of fexofenadine hydrochloride was established with nonaqueous potentiometric titration. Glacial acetic acid-acetic anhydride( 1 ∶ 3) was used as the solvent to avoid the use of mercuric acetate. Results: The optimized method had the sharpness titration jump. There was no significant difference between the results obtained by the improved method and HPLC method. Conclusion: The optimized method avoids the use of mercuric acetate. It is simple and rapid,and has the good repeatability. It can be used for the determination of fexofenadine hydrochloride.
引文
[1]杨云,颜耀东,刘茵,等.抗组胺药非索非那定的研究进展[J].中国药物应用与监测,2012,9(1):46YANG Y,YAN YD,LIU Y,et al.Research progress of the antihistamine drug fexofenadine[J].Chin J Drug Appl Monit,2012,9(1):46
[2]曾庆玲.盐酸非索非那定在变态反应性鼻炎中的临床应用[J].中国社区医师,2013,15(23):57
[3]黄辉云,唐桦,唐世清.盐酸非索非那定与氯雷他定对比治疗湿疹的疗效观察[J].中国医学创新,2013,10(14):33
[4]沙振方,张秉华,柳小琴,等.减少非水滴定中汞污染方法的探讨[J].中国药品标准,2004,5(2):14SHA ZF,ZHANG BH,LIU XQ,et al.Introduction of some methods of reducing mercury pollution in non-aqueous titration[J].Drug Stand China,2004,5(2):14
[5]张娜,岳志华,牛秀华,等.2010年版中国药典非水滴定中革除汞盐方法的探讨[J].药物分析杂志,2008,28(8):1405ZHANG N,YUE ZH,NIU XH,et al.Discussion an replacement of mercuric acetate in non-aqueous titration in Chinese pharmacopoeia volumeⅡ(edition 2010)[J].Chin J Pharm Anal,2008,28(8):1405
[6]刘翔,程泽能.非水滴定中汞污染问题及解决方法的研究进展[J].中南药学,2010,8(9):695l
[7]张轶华,韩学静,王晓琦.非水电位滴定法测定盐酸特比萘芬原料药含量方法的改进[J].中国药房,2010,21(29):2774ZHANG YH,HAN XJ,WANG XQ.Optimization of the determination method of terbinafine hydrochloride by non-aqueous potentiometric titration[J].China Pharm,2010,21(29):2274
[8]王晔.维生素B1高氯酸非水滴定方法的优化[J].中国药品标准,2010,11(5):349WANG Y.The optimum determination of Vitamin B1perchloric acid non-aqueous titration[J].Drug Stand China,2010,11(5):349
[9]USP.NF35[S].2016:4182
[2]曾庆玲.盐酸非索非那定在变态反应性鼻炎中的临床应用[J].中国社区医师,2013,15(23):57
[3]黄辉云,唐桦,唐世清.盐酸非索非那定与氯雷他定对比治疗湿疹的疗效观察[J].中国医学创新,2013,10(14):33
[4]沙振方,张秉华,柳小琴,等.减少非水滴定中汞污染方法的探讨[J].中国药品标准,2004,5(2):14SHA ZF,ZHANG BH,LIU XQ,et al.Introduction of some methods of reducing mercury pollution in non-aqueous titration[J].Drug Stand China,2004,5(2):14
[5]张娜,岳志华,牛秀华,等.2010年版中国药典非水滴定中革除汞盐方法的探讨[J].药物分析杂志,2008,28(8):1405ZHANG N,YUE ZH,NIU XH,et al.Discussion an replacement of mercuric acetate in non-aqueous titration in Chinese pharmacopoeia volumeⅡ(edition 2010)[J].Chin J Pharm Anal,2008,28(8):1405
[6]刘翔,程泽能.非水滴定中汞污染问题及解决方法的研究进展[J].中南药学,2010,8(9):695l
[7]张轶华,韩学静,王晓琦.非水电位滴定法测定盐酸特比萘芬原料药含量方法的改进[J].中国药房,2010,21(29):2774ZHANG YH,HAN XJ,WANG XQ.Optimization of the determination method of terbinafine hydrochloride by non-aqueous potentiometric titration[J].China Pharm,2010,21(29):2274
[8]王晔.维生素B1高氯酸非水滴定方法的优化[J].中国药品标准,2010,11(5):349WANG Y.The optimum determination of Vitamin B1perchloric acid non-aqueous titration[J].Drug Stand China,2010,11(5):349
[9]USP.NF35[S].2016:4182