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一种经过验证的反相高效液相色谱法,以盐酸吉西他滨为内标物测定片剂剂型中的拉帕替尼。

A Validated RP-HPLC Method for the Estimation of Lapatinib in Tablet Dosage form using Gemcitabine Hydrochloride as an Internal Standard.

作者信息

Kumar K K, Nagoji K E V, Nadh R V

机构信息

Department of Chemistry, Nalanda Degree and P.G. College, Bunder Road, Vijayawada-520 010, India.

出版信息

Indian J Pharm Sci. 2012 Nov;74(6):580-3. doi: 10.4103/0250-474X.110621.

DOI:10.4103/0250-474X.110621
PMID:23798787
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3687931/
Abstract

A simple, selective, rapid, precise and economical reverse-phase high-performance liquid chromatography method has been developed for the determination of lapatinib in tablet using gemcitabine hydrochloride as an internal standard. Chromatography was carried out on an ODS C-18 RP column (4.6 mm i.d. ×250 mm) using a mixture of acetonitrile and water (50:50 v/v) as the mobile phase at a flow rate of 1.0 ml/min. The drug was monitored at 232 nm. The retention times for lapatinib and gemcitabine hydrochloride were found to be 4.25±0.05 and 6.10±0.05 min, respectively. The method produced linear responses in the concentration range of 2-60 μg/ml of lapatinib. The limit of detection and limit of quantitation were 0.265 and 0.884 μg/ml, respectively.

摘要

已开发出一种简单、选择性好、快速、精确且经济的反相高效液相色谱法,以盐酸吉西他滨为内标物,用于测定片剂中的拉帕替尼。色谱分析在ODS C-18反相柱(内径4.6 mm×250 mm)上进行,使用乙腈和水的混合物(50:50 v/v)作为流动相,流速为1.0 ml/min。在232 nm波长处监测药物。拉帕替尼和盐酸吉西他滨的保留时间分别为4.25±0.05分钟和6.10±0.05分钟。该方法在拉帕替尼浓度范围为2 - 60 μg/ml时呈线性响应。检测限和定量限分别为0.265 μg/ml和0.884 μg/ml。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/17fe/3687931/93c8f4e9497b/IJPhS-74-580-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/17fe/3687931/7a7d647104a4/IJPhS-74-580-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/17fe/3687931/93c8f4e9497b/IJPhS-74-580-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/17fe/3687931/7a7d647104a4/IJPhS-74-580-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/17fe/3687931/93c8f4e9497b/IJPhS-74-580-g002.jpg

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An automated method for the measurement of a range of tyrosine kinase inhibitors in human plasma or serum using turbulent flow liquid chromatography-tandem mass spectrometry.一种使用湍流流液相色谱-串联质谱法测量人血浆或血清中多种酪氨酸激酶抑制剂的自动化方法。
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