茜素红荷移分光光度法测定特非那定的含量

目的: 建立电荷转移分光光度法测定特非那定含量。方法: 利用特非那定与茜素红在纯水溶液中发生荷移反应制成1:1的荷移络合物,再以其最大吸收波长522 nm进行测定,并计算含量。结果: 特非那定质量浓度在3.0~72.0 μg·mL^-1范围内与吸光度呈良好线性关系,线性相关系数r=0.998 2,检出限和精密度的RSD分别为0.87 μg·mL^-1和1.5%,表观摩尔吸光系数为5.424×10³ L·mol^-1·cm^-1。本方法用于测定特非那定片和胶囊中特非那定的含量,结果与药典方法基本一致,加样回收率为98.6%(片剂)和101.3%(胶囊)。结论: 本方法结果准确,重现性好,可用于特非那定片和胶囊含量的测定。

Objective: To establish a spectrophotometric method for terfenadine determination based on charge-transfer reaction. Methods: The 1:1 charge-transfer complex was prepared in water solution by charge-transfer reaction when terfenadine and alizarin red took place,and determined at the complex maximum absorption wavelength of 522 nm.Then,the content of terfenadine was calculated. Results: The linear range of the content was 3.0-72.0 μg·mL^-1,and the correlation coefficient was 0.998 2.The detection limit for this method was 0.87 μg·mL^-1, and RSD of precision was 1.5%.The apparent molar absorptivity of complex was 5.424×10³ L·mol^-1·cm^-1.The established method has been applied to the terfenadine determination in tablets and capsules.The results were in consistent with the data obtained by the pharmacopeia method.The recoveries were 98.6% for the tablets and 101.3% for the capsules. Conclusion: The established method is accurate and with good repeatability,which can be applied to the analysis of terfenadine in tablets and capsules.

[1] CHEN LS(陈柳生),LI HL(李鸿亮),WANG RY(王如意).Studies on determination method for the related substances of terfenadine tablets(特非那定片有关物质的检测方法研究)[J].Strait Pharm J(海峡药学),2013,25(9):89
[2] LU F(陆芳),JIN XL(金孝玲).Preparation of polyjuice terfenadine gelatum naristillae(复方特非那定凝胶滴鼻剂的制备)[J].China Pract Med(中国实用医药),2009,4(26):126
[3] SHENG WX(盛晚香),XIONG BY(熊邦义),YANG LQ(杨莲青).Terfenadine dispersible tablets in treating urticaria(特非那定分散片治疗荨麻疹)[J],Chin J New Drugs Clin Remed(中国新药与临床杂志),1998,17(4):223
[4] MENG YL(孟月兰),GUAN AH(管爱华),JIA LC(贾玲昌).Preparation of terfenadine oral suspension and its assay(特非那定口服混悬剂的制备及含量测定)[J],Chin J Hosp Pharm(中国医院药学杂志),1999,19(5):280
[5] CHENG B(程斌),LIU Q(刘启),WANG XY(王秀英).Measurement method for terfenadine tablet content(特非那定片的含量测定方法)[J].Chin J Hosp Pharm(中国医院药学杂志),2001,21(11):703
[6] LI LM(李丽敏),HAO B(郝彬).Determination of terfenadine concentration in human plasma by LC-MS(人血浆中特非那定的LC-MS测定法)[J].ChinJ Clin Pharmacol Therapeutics(中国临床药理学与治疗学),2009,14(4):432
[7] LONG N(龙娜).Content determination of related substances in terfenadine tablets by HPLC(HPLC法测定特非那定片中有关物质含量)[J].China Pharm(中国药房),2013,24(33):3145
[8] WU HW(吴海雯).Improvement on mobile phase of dissolution and determination of terfenadine tablets(特非那定片溶出度检查和含量测定流动相的改进)[J].J Pharm Pract(药物实践杂志),2007,25(2):98
[9] GHONEIN M,ISSA R,TAVFIK A.Assay of terfenadine in pharmaceutical for mulation and human plasma by adsorptive stripping voltammetry[J].J Pharm Biomed Anal,2001,26(4):593
[10] QIN YF(秦艳芳),WANG GQ(王广泉),CHANG YX(常银霞).Determination of terfenadine using cucurbituril-palmatine as fluorescence probe(以葫芦脲-盐酸巴马汀为荧光光探针测定特非那定)[J].J Hunan Univ Arts Sci:Nat Sci Ed(湖南文理学院学报:自然科学版),2011,23(4):49
[11] AIMAJAD AA,AIZEHOURI J,BELAI F,et al.Use of mixed anhydrides for the determination of terfenadine in dosage and spiked human plasma[J].Biomed Anal,2000,23:281
[12] ChP 2010.Vol Ⅱ(中国药典2010年版.二部)[S].2010:840