Simultaneous Analysis of Irbesartan and Hydrochlorothiazide: An Improved HPLC Method with the Aid of a Chemometric Protocol

Abstract

Experimental design method was used for HPLC determination of irbesartan and hydrochlorothiazide in combined dosage forms. The traditional approach for optimization of experiments is time-consuming, involves a large number of runs and does not allow establishing the multiple interacting parameters. The main advantages of the experimental design method include the simultaneous screening of a larger number of factors affecting response and the estimation of possible interactions. On the basis of preliminary experiments, three factors-independent variables were selected as inputs (methanol content, pH of the mobile phase and temperature) and as dependent variables, five responses (resolution, symmetry of irbesartan peak, symmetry of hydrochlorothiazide peak, retention factor of irbesartan and retention factor of hydrochlorothiazide) were chosen. A full 2 3 factorial design, where factors were examined at two different levels ("low" and "high") was used to determine which factors had an effect on the studied response. Afterwards, experimental design was used to optimize these influent parameters in the previously selected experimental domain. The novelty of our method lies in the optimization step accomplished by Derringers desirability function. After optimizing the OPEN ACCESSMolecules 2012, 17 3462 experimental conditions a separation was conducted on a Supelcosil C 18 (150 mm × 4.6 mm, 5 m particle size) column with a mobile phase consisting of methanol-tetrahydrofuranacetate buffer 47:10:43 v/v/v, pH 6.5 and a column temperature of 25 °C. The developed method was successfully applied to the simultaneous separation of these drug-active compounds in their commercial pharmaceutical dosage forms.

Simultaneous determination of aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide in their triple mixture dosage form by capillary zone electrophoresis

“…In CZE, the buffer type, pH, and concentration is a key strategy for optimizing the separation of ionizable analytes as it determines the degree of the analyte ionization, its electrophoretic mobility, and the magnitude of EOF. As ALS has a p K a value of 9.49 , AML has a p K a value of 8.7 , and HCZ has a p K a value 9.09 , ALS and AML are positively charged under acidic conditions and can be analyzed and separated from the unionized HCZ by CZE. Several running buffers such as phosphate, acetate, and borate at different pH values and molarities were tested for CZE analysis and the best results were obtained in phosphate buffer taking into consideration different parameters (migration time, resolution, peak shape, height, baseline noise, and the electric current produced).…”

Sensitive Extractional Colorimetric Analysis of Fexofenadine Hydrochloride and Irbesartan Bases Through Acid-Dye Complexation Using Naphthol Blue Black in Pure Form and Pharmaceuticals

“…Few methods have been described for the determination of irbesartan in pharmaceutical dosage forms by HPLC [28][29][30][31][32], extractive spectrophotometry with Picric acid, bromocresol green, bromothymol blue, cobalt thiocyanate and molybdenum (V) thiocyanate [33], spectrophotometry [34][35][36] and HPTLC [37]. Several HPLC [38][39][40][41][42][43][44][45], spectrophotometry [44][45][46][47][48][49][50] and capillary electrophoresis methods [51,52] are reported in the literature for the determination of irbesartan in combined pharmaceutical formulations.…”

Development and Validation of RP-HPLC Method for the Determination of Hydrochlorothiazide in Bulk Drug and Pharmaceutical Dosage Form

“…An extensive literature survey was carried out and found that there are few analytical methods for the determination of hydrochlorothiazide alone or in its combination with other drugs in pharmaceutical preparations including spectrophotometry [3,4], flow injection [5], TLC [6], and HPLC [7][8][9]. A recent study involved a review of developing methods using these analytical techniques for estimation of hydrochlorothiazide in various biological samples with focus on sample pretreatment methods and separation methods [10].…”