CONICET | Buscador de Institutos y Recursos Humanos

According to the USP 34 Magistral Preparation non sterile is the preparation, mixing, restoration, alteration, packaging and labeling of a drug according to the prescription, medication order or initiative to an authorized professional, based on the relationship between professional, patient, pharmacist and assistant in the professional practice. For all Magistral Preparation must be established Deadline of Use which is determined from the date of preparation and sets the time in which it can be used. The Magistral Preparation of our study is a complex preparation because it is a cream mixture of three active components, one of which capsaicin, and to not know its stability. In the present study evaluate capsaicin concentration at 1, 7, 15 and 30 days of preparation (until Deadline of Use), due to the complexity of this formulation is important to ensure the quality, safety and performance of compounded preparations throughout its usage time.To determine the concentration of capsaicin throughout the lifetime of Magistral Preparation the equipment used Dionex Ultimate 3000 with UV diode array detector set at 281 nm system. The chromatographic separation was carried out using a Lichrospher RP Select B column 150 mm x 4.6 mm. The mobile phase used was 0.1% phosphoric acid: acetonitrile (600:400) at a flow rate of 1 ml min-1. The injection volume was 20 ul. Capsaicin standard solution and sample solution were prepared in methanol at a concentration of 0.1 mg / ml. The chromatograms standard and samples at 1, 7, 15 and 30 days of preparation by determining the concentration of capsaicin at each time was obtained. The proposed method was applicable for the quantitative determination of capsaicin in complex Magistral Preparation verifying that before the Deadline of Use preserves concentrations within permitted limits. They are particularly useful for routine quality control and simultaneous quantification.