Desarrollo y validación de un método analítico HPLC para la valoración del salicilato de metilo en forma farmacéutica spray en el Laboratorio Neofarmaco del Ecuador CIA. LTDA

Abstract

The following research describes the development and validation of a reversed-phase highperformance chromatography (HPLC), method for the quantification of methyl salicylate in standard and pharmaceutically spray-loaded placebos. A LiChrospher® 100 RP-8 column (125 x 4 mm, 5um) was used. The mobile phase consisted of methanol and 1% ortho-phosphoric acid buffer using 60:40 gradient with a flow rate of 1 ml/min at 25°C. The sample injection volume was 10 ul. After method development, the method was validated according to Category 1 of the Analytical Procedures for the Quantification of Principal Components of Bulk Drugs or Active Ingredients in Finished Pharmaceutical Products, described in the USP for the validation of the method. It showed to be selective with a percentage discrepancy of areas 1.449 % and time 0.186%, linear for standard r=0.999979 (system linearity), placebo loaded (method 1 linearity) r= 0.999493 and for placebo loaded plus iodopovidone (method 2 linearity) r=0.999365, precise with a system repeatability of (RSD=0.2123), method (RSD=0.6328) and with an intermediate precision of (RSD= 0.567), accurate (recovery of 97.12%), and stable with a RSD not exceeding 20% degradation. After analyzing all these results. It was demonstrated that the analytical method developed and validated is suitable for the identification and quantification of methyl salicylate in spray pharmacological form. Besides, it can be applied for routine control in the laboratory.