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HPLC法测定尼洛替尼胶囊的含量
引用本文:张 敏,赵春才,徐健峰,徐家根. HPLC法测定尼洛替尼胶囊的含量[J]. 中国药房, 2014, 0(1): 69-70
作者姓名:张 敏  赵春才  徐健峰  徐家根
作者单位:[1]南京医科大学附属南京儿童医院,南京210008 [2]南京佳核鑫医药科技有限公司,南京210018
摘    要:
目的:建立测定尼洛替尼胶囊含量的方法。方法:采用高效液相色谱法。色谱柱为Kromasil C18,流动相为0.02 mol/L乙酸铵-甲醇(20∶80),流速为1.0 ml/min,紫外检测波长为268 nm,进样量为20μl。结果:尼洛替尼检测质量浓度线性范围为40.08360.7μg/m(lr=0.999 9),平均回收率为99.46%(RSD=0.41%,n=3)。结论:本方法操作简便、快捷,结果准确、可靠,可用于尼洛替尼胶囊的质量控制。

关 键 词:高效液相色谱法  尼洛替尼胶囊  含量测定

Content Determination of Nilotinib Capsules by HPLC
ZHANG Min,ZHAO Chun-cai,XU Jian-feng,XU Jia-gen. Content Determination of Nilotinib Capsules by HPLC[J]. China Pharmacy, 2014, 0(1): 69-70
Authors:ZHANG Min  ZHAO Chun-cai  XU Jian-feng  XU Jia-gen
Affiliation:1.Nanjing Children's Hospital Affiliated to Nanjing Medical .University, Nanjing 210008, China; 2.Nanjin Jiahexin Pharmaceutical Co., Ltd., Nanjing 210018, China)
Abstract:
OBJECTIVE: To establish a method for the content determination of Nilotinib capsules. METHODS: HPLC method was adopted. The determination was performed on Kromasil C18 column with mobile phase consisted of 0.02 mol/L ammonium ace- tate buffer-methanol (20:80) at flow rate of 1.0 ml/min. UV detection wavelength was set at 268 nm, and sample size was 20 μl. RESULTS: The linear range of nilotinib was 40.08-360.7 μg/ml (r=0.999 9) with an average recovery of 99.46% (RSD=0.41%, n = 3). CONCLUSIONS: This method is simple, rapid, accurate and reliable, and it is suitable for the quality control of Nilotinib capsules.
Keywords:HPLC  Nilotinib capsules  Content determination
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