An eco-friendly micellar HPLC method for the simultaneous determination of triamterene and xipamide in active pharmaceutical ingredients and marketed tablet dosage form

Abstract

AbstractIn the last few years, the use of surfactants as mobile phase additives in reversed phase liquid chromatography (RPLC) has been steadily developing and improving. Surfactants modify the polarity of the stationary phase which in turn decreases the amount of organic solvent required for elution of the analytes rendering the methodologies linked to them greener and more eco-friendly. Brij-35 is a fatty alcohol ethoxylates non ionic surfactant, which is less widely used as mobile phase additive. Brij-35 can decrease stationary phase polarity while remaining neutral. In this research, Brij-35 was studied in the separation and determination of marketed antihypertensive combination therapy composed of triamterene (TRM) and xipamide (XIP). TRM and XIP are diuretics used for treatment of essential hypertension and associated edema conditions. Chromatographic separation was achieved on RP-C18 column (Kinetix®, 5 µm, 15 cm × 4.6 mm) at flow rate 1  mL  min−1 and UV-detection at 254 nm. Isocratic elution was performed using mobile phase composed of 0.1 M Brij-35: methanol (MeOH) (60:40, v/v). The analytes were well separated and quantified within linearity ranges of 5–50 µg mL−1 for both drugs in short retention time (2.6 and 5.3 min. for TRM and XIP, respectively). Since claiming greenness is not enough, Green Analytical Procedure Index (GAPI) was used to demonstrate the superiority of the proposed method over the previously reported methods. GAPI is a new metric for evaluation of the ecological impact of analytical procedures. The proposed method was validated according to ICH guidelines and applied successfully for simultaneous determination of the drugs in their co-formulated tablets.