Características fisicoquímicas del ingrediente farmacéuticamente activo en tabletas de losartán potásico 50 mg adquiridos por el estado peruano y sector privado

Abstract

The active pharmaceutical ingredient (API) is used in drugs formulation. The objective was to determine the physicochemical characteristics of the secondary standard and compare it with the API contained in potassium losartan (PL) 50mg tablets purchased by the Peruvian state and marketed by the private sector, to assess their similarity. A secondary standard and tablets from 7 pharmaceutical laboratories (public sector, innovative and multi-sources 1 to 5) were analyzed, infrared spectroscopy (IR) methods in the range of 4000 to 450 cm-1 and differential scanning calorimetry (DSC) from 30 to 300 °C with ramp of 10 °C/min, were used. Vibration signals were obtained in IR of 3522-3524 cm-1 (N-H), 3179-3334 cm-1 (O-H), 1577- 1581 cm-1 (C=N) and 762-763 cm-1 (C-Cl), for the case of the secondary standard, multi-source-1 and multi-source-5, the N-H signal did not appear. In the DSC for the secondary standard, two endotherms with melting points of 237.62 and 270.33 °C corresponding to the polymorphs form I and form II were found, respectively. The LP 50 mg tablets did not report these endotherms. It is concluded that the API of the LP 50mg tablets is not similar to the secondary standard.

Keywords

• potassium losartan
• active pharmaceutical ingredient
• spectroscopy fourier transform infrared
• calorimetry differential scanning.