Abstract
Lapatinib is a small molecule, a heterocyclic quinazoline derivative. The drug is used for targeted therapy of patients with breast cancer, in which there is overexpression of the human epidermal growth factor receptors (HER/ErbB). This review is devoted to studying modern instrumental methods of qualitative and quantitative analysis of lapatinib, which can be used both for quality control and standardization (of bulk pharmaceuticals and dosage forms) and pharmacokinetics studies of a drug. Reverse-phase high-performance liquid chromatography (RP-HPLC) is mainly used to identify lapatinib in tablets. Depending on the purpose of the study, various detectors are used (ultraviolet or diode-matrix detector), which makes it possible to determine not only the native compound but also the products of its degradation. Definition of lapatinib in the presence of degraded products is necessary for forced degradation studies to determine drug stability. When a drug is being developed, it is important to define and understand its pharmacokinetics. For such studies, high-performance liquid chromatography (HPLC) coupled with the mass selective detector is often used. It allows determining lapatinib in biological fluids. However, these methods are not applicable for identifying the drug directly in dosage forms and require further development and validation.
Highlights
Breast cancer is the most common malignant tumor in women in the world [1]
Overexpression or activation of the HER/ErbB is often observed in breast cancer
One of the treatment options for such patients is the use of targeted therapy, which is aimed at disrupting specific biological processes that lead to tumor growth [3]
Summary
Breast cancer is the most common malignant tumor in women in the world [1]. Overexpression or activation of the HER/ErbB is often observed in breast cancer. For the determination of lapatinib in tablets, a simple, selective, fast, accurate, and cost-effective method of reverse-phase highperformance liquid chromatography coupled with an ultraviolet detector (RP-HPLC-UV) using an internal standard (IS) has been developed [26]. A simple and sensitive method of RP-HPLC-UV was developed to determine lapatinib together with related impurities in the bulk pharmaceuticals and finished tablets [27].
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