| HPLC法测定二甲苯磺酸拉帕替尼片中拉帕替尼的含量 |
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| 引用本文： | 徐家根,赵春才,陆超,陈丽. HPLC法测定二甲苯磺酸拉帕替尼片中拉帕替尼的含量[J]. 中国药房, 2012, 0(37): 3524-3525 |
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| 作者姓名： | 徐家根 赵春才 陆超 陈丽 |
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| 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 [3]苏州卡耐博生物技术有限公司,江苏张家港215600 |
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| 摘 要： | 目的:建立测定二甲苯磺酸拉帕替尼(LD)片中拉帕替尼含量的方法。方法:采用高效液相色谱法。色谱柱为KromasilC18,流动相为0.01mol·L-1K2HPO4缓冲液-甲醇(20∶80),流速为1.0mL·min-1,检测波长为262nm,进样量为20μL。结果:拉帕替尼检测浓度的线性范围为20.14～181.3μg·mL-(1r=0.9999);平均回收率为99.35%(RSD=0.38%)。结论:本方法操作简便快捷,结果准确可靠,可用于LD片的质量控制。
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| 关 键 词： | 二甲苯磺酸拉帕替尼片 高效液相色谱法 含量测定 |
Content Determination of Lapatinib in Lapatinib Ditosylate Tablets by HPLC ] |
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| XU Jia-gen Nanjing Children＇ s Hospital Affiliated to Nanjing Medical University,Nanjing,China ZHAO Chun-cai,CHEN Li. Content Determination of Lapatinib in Lapatinib Ditosylate Tablets by HPLC ][J]. China Pharmacy, 2012, 0(37): 3524-3525 |
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| Authors: | XU Jia-gen Nanjing Children＇ s Hospital Affiliated to Nanjing Medical University Nanjing China ZHAO Chun-cai CHEN Li |
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| Affiliation: | (Nanjing Jiahexin Pharmaceutical Co., Ltd., Nanjing 210018, China) LU Chao(Suzhou Canimble Biotechnology Co., Ltd., Jiangsu Zhangjiagang 215600, China) |
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| Abstract: | OBJECTIVE： To establish a method for the content determination of lapatinib in Lapatinib ditosylate tablets. METH- ODS： HPLC method was adopted. The separation was performed on Kromasil C18 column with mobile phase consisted of 0.01 mol. L-1K2HPO4 buffer-methanol （20：80） at the flow rate of 1.0 mL-min 1. The detection wavelength was set at 262 nm and the injec- tion volume was 20 μL. RESULTS： The linear range of lapatinib was 20.14-181.3 ktg.mL-1 （r=0.999 9）with an average recov- ery of 99.35% （RSD=0.38%）. CONCLUSION： The method is simple, rapid, accurate and reliable, and it is applicable for the quality control of Lapatinib ditosylate tablets. |
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| Keywords: | Lapatinib ditosylate tablet HPLC Content determination |
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