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.
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.
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。
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