Otimização e desenvolvimento de uma metodologia de cromatografia líquida de alta eficiência para determinação de fármacos anti-hipertensivos

Abstract

The pharmaceutical market in recent years is being represented as a growing economic category, emerging as one of highest-grossing national sectors. With this method of analytical quality analysis of pharmaceutical products is essential, as quality control, quality and sales in pharmaceuticals. Another tool still little explored and used in wich for the development of methodologies is the Desing of Experiments with multiple responses and that allows optimizing methods faster and more efficiently.With that, this study proposes application the experimental design with Derringer’s desirability function the determination the Losartan potassium (LOS) and Hydrochlorithiazide (HCTZ) function in the determination tablet dosage form, synthetic urine and river surface water by high performance liquid chromatography (HPLC) with diode array detector. By using central composite design with desirability function, the best condition was obtained with isocratic elution; mobile phase of phosphoric acid 0.1%: acetonitrile (60:40, v/v); temperature of 40.0 °C and flow rate of 0.8 mL min-1. The validated method, used Huber test which enabled set the working range for LOS and HCTZ 0.2-5.0 μg mL-1 with residues below 5.0% and correlation coefficient 0.9999. The limit quantification for LOS and HCTZ was 0.032 and 0.010 μg mL-1 respectively, and limit detection was 0.010 μg mL-1 LOS and 0.003 μg mL-1 HCTZ. The developed method was applicated in tablet dosage form and synthetic urine and obtaining appropriate recoveries good precision and accuracy.