Estudo de degradação forçada e desenvolvimento de método indicativo de estabilidade para determinação de naproxeno sódico.

Abstract

In order to guarantee pharmacotherapeutic success, every drug must present efficacy, safety and quality. In addition, these characteristics are necessary for the sanitary registration of the pharmaceutical products. Stability is an important factor to ensure this triad. The lack of stability may be related to the loss of the therapeutic effect or the exposure of consumers to degradation products, which can have toxic effects. In this context, methods capable of detecting and quantifying possible changes in the formulation are required. Such stability indicating methods must be selective for the drug under analysis and allow its quantification and identification as well as its degradation products. Non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic and anti-inflammatory effects, are among the most used drugs worldwide. Naproxen sodium (NAP Na+) is a commonly used NSAID. In this context, a forced degradation study of the active pharmaceutical ingredient NAP Na+ and the tablets containing this drug was carried out. A stability indicating method was developed and validated using ultra high performance liquid chromatography coupled to a diode array detector in a C18 (50 x 2.1 mm; 1.7 µm) column. In addition, thermal analyzes (differential scanning calorimetry and thermogravimetry) were performed to analyze the compatibility between the active pharmaceutical ingredient and the excipients of the formulation. The chromatographic method was selective for NAP and its degradation products. In the forced degradation study, the drug was stable under mild degradation conditions, but was susceptible to degradation when exposed to drastic conditions in acid and alkaline medium. Low-intensity interactions were observed between NAP Na+ with lactose and polyvinylpyrrolidone. As a conclusion, it can be stated that the stability indicating method developed and validated can be used in stability and quality control studies, assuring the efficacy, safety and quality of the drug.